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Device Explorer · FDA GUDID · GMDN 38530

Dental spatula, reusable

A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.

US‑registered devices807in commercial distribution
Companies41labelers on GUDID
Single‑use8%of device records
Sterile2%labelled sterile
Prescription25%Rx‑only share
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Share of device records

Power Dental U.S.A. Inc.10613%
Aesculap Ag10012%
Lm-Dental8210%
Hu-Friedy Mfg. Co., Llc8110%
American Eagle Instruments, Inc.688%
Zoll-Dental668%
Plasdent Corporation344%
Schobell Industrial Ltda304%

Top labelers

CompanyDevicesShare
Power Dental U.S.A. Inc.10613%
Aesculap Ag10012%
Lm-Dental8210%
Hu-Friedy Mfg. Co., Llc8110%
American Eagle Instruments, Inc.688%
Zoll-Dental668%
Plasdent Corporation344%
Schobell Industrial Ltda304%
Henry Schein, Inc.263%
Densol International (Private) Limited213%
Nordent Manufacturing Inc192%
J & J Instruments Inc162%

Company = labeler of record on GUDID. 41 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Enamel Plus Stain & InstrumentsLMDentalKOHDENTReicodentdevemedAESCULAPMediconERGOPLANTDarby Dental Supply, LLCSPATULAFILLERPower Dental U.S.A., Inc.Power Dental USASPATULA-24ASPATULA 24Premium Plus

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

FDA product codes

CodeNameDevices
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL243
DZNInstruments, Dental Hand120
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY88
DZNINSTRUMENTS, DENTAL HAND57
GAFSpatula, Surgical, General & Plastic Surgery46
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE45

GMDN & GCC registration

  • GMDN code 38530 · non‑implantable
  • Single‑use 8% · sterile 2% · Rx‑only 25% · OTC 1%
  • 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) · 6Width (Millimeter) · 4Height (Millimeter) · 4Length (Inch) · 2

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

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

807 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental spatula, reusable", from 41 companies. The largest labeler is Power Dental U.S.A. Inc. with 13% of records.

Which FDA product codes apply?

EIY (INSTRUMENT, FILLING, PLASTIC, DENTAL), DZN (Instruments, Dental Hand), GAF (SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY), DZN (INSTRUMENTS, DENTAL HAND)

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.

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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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