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Device Explorer · FDA GUDID · GMDN 63358

Dental abrasive strip, reusable

A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a re

US‑registered devices333in commercial distribution
Companies12labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription24%Rx‑only share
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Share of device records

M.D.T. - Micro Diamond Technologies Ltd.12136%
Abrasive Technology, Inc.4112%
Edenta Etablissement3711%
Diamond Strauss Instruments Inc288%
Henry Schein, Inc.247%
Gebr. Brasseler Gmbh & Co. Kg196%
Young Innovations, Inc.155%
Dentsply Sirona Orthodontics Inc.155%

Top labelers

CompanyDevicesShare
M.D.T. - Micro Diamond Technologies Ltd.12136%
Abrasive Technology, Inc.4112%
Edenta Etablissement3711%
Diamond Strauss Instruments Inc288%
Henry Schein, Inc.247%
Gebr. Brasseler Gmbh & Co. Kg196%
Young Innovations, Inc.155%
Dentsply Sirona Orthodontics Inc.155%
Gni Co.,Ltd155%
Nti - Kahla Gmbh Rotary Dental Instruments124%
Bioclear Matrix Systems41%
Micerium Spa21%

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

Brand names on the register (sample)

MDT Diamond Coated Dental Flexible StripsEna PostEDENTANTIKOMET Diamond Strip, Polishing StripTruContact KitTruContactThe Orthodontic StoreDefendFlexview®N/AStrauss DiamondHenry ScheinProdiaTwo StriperSB-90HL

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

FDA product codes

CodeNameDevices
EHMSTRIP, POLISHING AGENT157
DZPINSTRUMENT, DIAMOND, DENTAL58
EHMStrip, Polishing Agent48
DZPInstrument, Diamond, Dental31
EHJDISK, ABRASIVE19
HRTStripper, Surgical15

GMDN & GCC registration

  • GMDN code 63358 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 24% · 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

Length (Millimeter) · 2Height (Millimeter) · 2

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

How many dental abrasive strip, reusable products are registered in the US?

333 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental abrasive strip, reusable", from 12 companies. The largest labeler is M.D.T. - Micro Diamond Technologies Ltd. with 36% of records.

Which FDA product codes apply?

EHM (STRIP, POLISHING AGENT), DZP (INSTRUMENT, DIAMOND, DENTAL), EHM (Strip, Polishing Agent), DZP (Instrument, Diamond, Dental)

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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