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Device Explorer · FDA GUDID · GMDN 44883

Dental implant/prosthesis surgical procedure kit

A collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque

US‑registered devices1,398in commercial distribution
Companies25labelers on GUDID
Single‑use68%of device records
Sterile0%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Sweden & Martina Spa1,07577%
Hi-Tec Implants Ltd.1178%
Megagen Implant Co. Ltd675%
Zimvie Us Corp Llc302%
Cowellmedi Co.,Ltd262%
Adin Dental Implant Systems Ltd181%
Quantum Bioengineering Ltd.121%
Implant Direct Sybron Manufacturing Llc81%

Top labelers

CompanyDevicesShare
Sweden & Martina Spa1,07577%
Hi-Tec Implants Ltd.1178%
Megagen Implant Co. Ltd675%
Zimvie Us Corp Llc302%
Cowellmedi Co.,Ltd262%
Adin Dental Implant Systems Ltd181%
Quantum Bioengineering Ltd.121%
Implant Direct Sybron Manufacturing Llc81%
Dentin Implants Technologies Ltd60%
Bhi Implants Ltd50%
Southern Implants (Pty) Ltd50%
Argon Medical Productions & Vertriebs Gesellschaft Mbh & Co. Kg50%

Company = labeler of record on GUDID. 25 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

IMPLANTOLOGY TOOLSSURGICAL KITSurgical KitUNIVERSAL UNITSELF THREAD/LOGIC PLUS/SPARKSURGICAL INSTRUMENTATIONSurgical BoxDepth ProbeParallel PinAdin Wide Short Drill Stop KitAdin Regular Short Drill Stop KitAdin Wide Long Drill Stop KitAdin Regular Long Drill Stop KitRS-Standard Internal Hex Plastic Surgical Kit-StRS-Standard Internal Hex Plastic Surgical Kit-StRS-Standard Internal Hex Plastic Surgical Kit-S

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NDPAccessories, Implant, Dental, Endosseous1,198
NHAAbutment, Implant, Dental, Endosseous118
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS31
OFYDental Implant Surgical Tray18
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS13
KCTSterilization Wrap Containers, Trays, Cassettes & Other Acce8

GMDN & GCC registration

  • GMDN code 44883 · non‑implantable
  • Single‑use 68% · sterile 0% · Rx‑only 89% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 15Length (Millimeter) · 14Length (Centimeter) · 2

Use these as the dimensions to specify in a tender line.

How many dental implant/prosthesis surgical procedure kit products are registered in the US?

1,398 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant/prosthesis surgical procedure kit", from 25 companies. The largest labeler is Sweden & Martina Spa with 77% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NHA (Abutment, Implant, Dental, Endosseous), NDP (ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS), OFY (Dental Implant Surgical Tray)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

Add dental implant/prosthesis surgical procedure kit to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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