Lucae Tuning Fork — C1 128 Hz Low-Frequency

$ 0

Lucae -Tuning forks – ENT

MOQ: 50 pieces
Lead time: 18–22 working days
Sample order: 10 units · sample fee credited against first PO
OEM private label: Private-label from 300 units per SKU
Materials: Surgical-grade stainless steel
Sterilization: Steam autoclave to 134 °C · EtO compatible
Certifications: ISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered
Shipping: DHL Express · UPS · FedEx · sea freight · all Incoterms

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SKU TF 15-250-00 Categories ,
Regulatory Nomenclature
EMDN (EUDAMED): V020309
GMDN Code: 36101
Tuning fork

Lucae Tuning Fork — C1 128 Hz Low-Frequency — catalogue reference TF 15-250-00.

Reference / SKUTF 15-250-00
MaterialSurgical-grade stainless steel
SterilizationSteam autoclave to 134 °C · EtO compatible
Quality systemISO 13485:2016 · CE-marked under EU MDR 2017/745 · FDA establishment-registered

Dental instruments cover extraction forceps, elevators, excavators, scalers, scissors, mirror handles, and specialty patterns for endodontic and periodontal work. Extraction forceps are the workhorses — English-pattern (rotational grip) and American-pattern (lateral grip) cover the major tooth groups: incisors, canines, premolars, molars in both upper and lower arches. Dental scaler patterns (Gracey, Columbia, Younger-Good) target specific tooth surfaces during periodontal treatment. Elevators (Coupland, Cryer, Winter) loosen teeth before extraction. Modern dental instruments are manufactured from AISI 420 stainless for autoclavability and corrosion resistance; tungsten-carbide tips appear on scaler and curette variants where edge retention matters most. Fizza manufactures full dental sets to ISO 13485:2016.

Fizza Surgical International has manufactured surgical instruments at its Sialkot, Pakistan facility since 1980 — more than four decades of continuous operation under one family ownership. The factory holds ISO 13485:2016 certification for medical devices and CE marking under EU MDR 2017/745, the regulatory baseline European hospitals and distributors require. FDA establishment registration covers exports to the United States.

What is the minimum order quantity for Fizza Surgical instruments?
Standard MOQ is 300 units per SKU for catalogue items, 500 units for fully custom designs. Sample orders of 10 units per SKU are available with the sample fee credited against the first production order.
Are Fizza Surgical instruments CE-marked and ISO 13485 certified?
Yes. All instruments are manufactured under an ISO 13485:2016 Quality Management System, CE-marked under EU MDR 2017/745, and our facility is FDA-registered. Specific certificate numbers and PDFs are on our Certifications page.
How long is the lead time and what shipping options are available?
18–22 working days for catalogue items, 28–35 days for custom designs. Shipping via DHL Express, UPS, FedEx, or sea freight on all standard Incoterms (EXW, FCA, FOB, CIF, DAP).
Can I order a custom OEM private-label run with my own branding?
Yes — private-label manufacturing from 300 units per SKU. Co-branded packaging, custom instrument-set design, and laser etching with your brand are all available.

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