Consulting Wallah › Device Explorer › Dental › Dental/maxillofacial surgical procedure kit, non-m
Device Explorer · FDA GUDID · GMDN 45147

Dental/maxillofacial surgical procedure kit, non-medicated, reusable

A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

US‑registered devices2,950in commercial distribution
Companies80labelers on GUDID
Single‑use13%of device records
Sterile0%labelled sterile
Prescription79%Rx‑only share
ShareLinkedIn

Share of device records

Izenimplant Co., Ltd.52918%
Dentium Co., Ltd.50817%
Warantec.Co.,Ltd2117%
Mis Implants Technologies Ltd.1927%
Osstem Implant Co., Ltd.1615%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung1415%
Megagen Implant Co. Ltd853%
Ditron Dental Ltd753%

Top labelers

CompanyDevicesShare
Izenimplant Co., Ltd.52918%
Dentium Co., Ltd.50817%
Warantec.Co.,Ltd2117%
Mis Implants Technologies Ltd.1927%
Osstem Implant Co., Ltd.1615%
Hager & Meisinger Gesellschaft Mit Beschränkter Haftung1415%
Megagen Implant Co. Ltd853%
Ditron Dental Ltd753%
Dentis Co. ,Ltd712%
Sweden & Martina Spa702%
Sin Sistema De Implante Nacional S/A652%
Surgident Co.,Ltd.542%

Company = labeler of record on GUDID. 80 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FRIOS®FRIADENT®XiVE®ANKYLOS® Surgical Kit Guided SurgeryANKYLOS® Surgical Kit motor AB reamerANKYLOS® Surgical Kit manual ABANKYLOS® Surgical Kit manual ABCBrånemark System®Ditron DentalMIS kitMISZygomatic Surgical Kit, Standard HexSS SafeDepth KitSafeDepth KitSS SafeDepth TraySafeDepth Tray

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, Endosseous1,056
NDPAccessories, implant, dental, endosseous702
DZADrill, Dental, Intraoral379
NYEFixture Mount Kit174
KCTSterilization wrap containers, trays, cassettes & other acce97
OFYDental Implant Surgical Tray91

GMDN & GCC registration

  • GMDN code 45147 · non‑implantable
  • Single‑use 13% · sterile 0% · Rx‑only 79% · 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) · 326Length (Millimeter) · 217Width (Millimeter) · 9Height (Millimeter) · 8Length (Centimeter) · 7Width (Centimeter) · 4

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

How many dental/maxillofacial surgical procedure kit, non-medicated, reusable products are registered in the US?

2,950 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental/maxillofacial surgical procedure kit, non-medicated, reusable", from 80 companies. The largest labeler is Izenimplant Co., Ltd. with 18% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), NDP (Accessories, implant, dental, endosseous), DZA (Drill, Dental, Intraoral), NYE (Fixture Mount Kit)

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/maxillofacial surgical procedure kit, non-medicated, reusable 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.

Request quotes for Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying dental/maxillofacial surgical procedure kit, non-m for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →