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Device Explorer · FDA GUDID · GMDN 63662

Dental implant suprastructure reamer

A manually-operated dental laboratory instrument intended to be used to smooth and refine the surface of the screw channel, screw seat and implant/abutment connection of a dental implant suprastructure, by means of a rotating abrasive action. It is used to rem

US‑registered devices101in commercial distribution
Companies8labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription60%Rx‑only share
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Share of device records

Osstem Implant Co., Ltd.4343%
Truabutment Korea Co.,Ltd2626%
Young Innovations, Inc.99%
Southern Implants (Pty) Ltd88%
Jjgc Indústria E Comércio De Materiais Dentários S/A.66%
Thommen Medical Ag55%
Preat Corporation22%
Institut Straumann Ag22%

Top labelers

CompanyDevicesShare
Osstem Implant Co., Ltd.4343%
Truabutment Korea Co.,Ltd2626%
Young Innovations, Inc.99%
Southern Implants (Pty) Ltd88%
Jjgc Indústria E Comércio De Materiais Dentários S/A.66%
Thommen Medical Ag55%
Preat Corporation22%
Institut Straumann Ag22%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/ANAJohnson-PromidentPreatReamer TipReamer BiteOneGuide Reamer DrillOneGuide ReamerTS Rigid Reamer TipFinishing ReamerDirect Screw Reamer StopperDirect Screw Final ReamerDirect Screw Initial ReamerCone ReamerBase ReamerTru Reamer Kit

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, Endosseous54
EJLBur, Dental26
NDPAccessories, implant, dental, endosseous14
DZADRILL, DENTAL, INTRAORAL9
DZADrill, Dental, Intraoral2
EGGATTACHMENT, PRECISION, ALL1

GMDN & GCC registration

  • GMDN code 63662 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 60% · 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) · 4Angle (degree) · 1Length (Millimeter) · 1

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

How many dental implant suprastructure reamer products are registered in the US?

101 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental implant suprastructure reamer", from 8 companies. The largest labeler is Osstem Implant Co., Ltd. with 43% of records.

Which FDA product codes apply?

NDP (Accessories, Implant, Dental, Endosseous), EJL (Bur, Dental), NDP (Accessories, implant, dental, endosseous), DZA (DRILL, DENTAL, INTRAORAL)

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?

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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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