Dental Instruments Manufacturer | ISO 13485 & CE Certified

Export Quality Manufacturing

ISO 13485 & CE Certified Dental Instruments Manufacturer in Sialkot, Pakistan

Fizza Surgical International is an established manufacturer and global exporter of precision dental instruments. Operating from Sialkot, Pakistan — the international manufacturing hub for surgical steel — our facility produces over 1,840 distinct dental instrument models covering diagnostic, restorative, periodontic, endodontic, surgical extraction, and orthodontic disciplines.

Every tool is forged using high-grade German and Japanese stainless steel alloys (AISI 410, AISI 420, and AISI 440C), engineered to meet stringent DIN EN ISO 13485:2016 quality systems and CE MDR Class I standards. Our instruments feature anti-glare satin finishes, ergonomic knurled handles, and precision-tempered working tips built to endure repeated autoclave sterilization at 134°C (273°F) without corrosion or structural degradation.

Manufacturing Capabilities & OEM Standards

ISO 13485:2016 Certified Quality Management
CE Marked & FDA Establishment Registered (#3019842214)
ASTM A967 Standard Chemical Passivation
Private Label Laser Marking & Custom Packaging (MOQ 300 Pcs)
Direct Factory Wholesale Lead Times (10–20 Days Dispatch)

Product Classification

Complete Dental Instrument Catalog & Specialties

Explore our comprehensive portfolio engineered for clinical performance, tactile feedback, and maximum durability across all dental specializations.

176 Models

Tooth Extracting Forceps

English and American pattern extraction forceps forged with anatomically contoured beaks, teethed tips, and heavy-duty spring joints for incisors, premolars, molars, and wisdom teeth.

144 Models

Root Elevators & Luxators

Bein, Cryer, Apexo, Heidbrink, and Coupland elevators. Precision ground sharp working blades with hollow hexagonal or knurled round handles for atraumatic tooth extraction.

120 Models

Periodontal Scalers & Curettes

Gracey curettes (1/2 through 17/18), Sickle scalers, Universal curettes (Barnhart, Columbia), and periodontal pocket probes with laser-marked millimeter graduations.

86 Models

Diagnostic Explorers & Mirrors

Single and double-ended explorers (#23 Shepherds Crook, DG16, #6), college dressing pliers, and rhodium front-surface anti-fog mouth mirrors with ergonomic handles.

161 Models

Orthodontic Pliers & Cutters

Tungsten Carbide tipped hard wire cutters, distal end cutters with safety hold, Weingart pliers, Adams pliers, torque pliers, and bracket positioning gauges.

130 Models

Implantology & Micro-Surgery

Sinus lift elevators, osteotomes, bone scrapers, trephine burs, tissue punch tools, bone rongeurs, and tunneling micro-curettes engineered for oral implant surgery.

95 Models

Stainless Steel Impression Trays

Perforated and solid stainless steel impression trays for dentulous and edentulous arches, pediatric trays, and section trays constructed for accurate impression molding.

118 Models

Endodontic & Restorative Tools

Amalgam carriers, pluggers, burnishers, carvers (Cleoid-Discoid, Hollenback), excavators, rubber dam clamps, and forceps for root canal & restorative procedures.

Engineering Rigor

Manufacturing Specifications & Quality Control

Our production facilities utilize modern forge presses, computerized heat-treatment furnaces, and microscopic inspection stages to guarantee clinical precision.

1. Material Selection & Metallurgy

We source certified AISI 420 and 440C martensitic stainless steel for high tensile strength and edge retention, alongside AISI 304/316 austenitic steel for non-cutting holloware. Tungsten Carbide (TC) inserts are vacuum-brazed to cutting jaws to reach 60–62 HRC hardness.

2. Precision Heat Treatment & Hardening

Instruments undergo vacuum heat treatment followed by cryo-quenching. This precise metallurgical process balances flexibility with maximum Rockwell hardness (50–54 HRC for pliers and elevators), preventing beak distortion or stress fractures under heavy torque.

3. Passivation & Autoclave Resistance

Following final hand-polishing and ultrasonic cleaning, all instruments pass chemical passivation according to ASTM A967 standards. This establishes a dense chromium-oxide passive surface layer that resists pitting, staining, and rust across thousands of autoclave cycles.

Procurement Reference

Dental Instrument Technical Specifications Table

Standard manufacturing specifications for international dental distributors and hospital purchasing departments.

Product Category	Stainless Steel Grade	Hardness Range (HRC)	International Standards	Sterilization Compatibility	OEM MOQ
Extracting Forceps	AISI 420 Stainless Steel	50 - 54 HRC	ISO 13485 / CE / DIN 58298	Autoclave 134°C / Dry Heat	300 Units
Root Elevators & Luxators	AISI 420 / French Steel	52 - 56 HRC	ISO 13485 / CE / ASTM F899	Autoclave 134°C / Ultrasonic	300 Units
Scalers & Gracey Curettes	High-Carbon AISI 440C	56 - 58 HRC	ISO 13485 / CE / ISO 7153-1	Autoclave 134°C / Chemclave	500 Units
Orthodontic Pliers (TC)	AISI 420 + TC Inserts	60 - 62 HRC (TC Jaw)	ISO 13485 / CE / FDA Registered	Autoclave 134°C / Steam	200 Units
Diagnostic Explorers / Probes	AISI 302 / 410 Steel	46 - 50 HRC	ISO 13485 / CE Marked	Autoclave 134°C / Dry Heat	500 Units
Impression Trays	AISI 304 Non-Magnetic SS	Corrosion Resistant	ISO 9001:2015 / CE Class I	Autoclave 134°C / Thermo-disinfector	300 Units

B2B Buyer FAQ

Frequently Asked Questions for International Procurement

Direct answers regarding order quantities, compliance documentation, private labeling, and export shipping logistics.

Q: What is your Minimum Order Quantity (MOQ) for dental orders?

A: Our standard MOQ for standard catalogue dental instruments starts at 300 units per category. For custom private label OEM projects with specific laser branding and tailored packaging, MOQ starts from 300 to 500 units depending on the instrument pattern.

Q: Do your dental instruments comply with EU MDR and US FDA regulations?

A: Yes. Fizza Surgical International is ISO 13485:2016 and ISO 9001:2015 certified by recognized bodies. Our medical devices bear the CE Mark under EU Medical Device Regulations (MDR Class I) and are registered with the US FDA (Establishment Registration #3019842214).

Q: Can you manufacture custom dental tools or private label branding?

A: We provide comprehensive OEM and Private Label manufacturing services. This includes custom laser etching of your brand logo and item SKU, custom handle knurling patterns, specialized tip geometries, and retail-ready blister or leather pouch packaging.

Q: What are your standard delivery lead times for global shipments?

A: Standard manufacturing and dispatch lead times range between 10 to 20 working days following order confirmation and deposit approval. Express air freight shipments via DHL, FedEx, or air cargo typically arrive in North America and Europe within 4 to 7 business days.

Dental Instruments