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Device Explorer · FDA GUDID · GMDN 35320

Manual dental scaler, reusable

A hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of vari

US‑registered devices4,008in commercial distribution
Companies48labelers on GUDID
Single‑use5%of device records
Sterile2%labelled sterile
Prescription20%Rx‑only share
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Share of device records

Nordent Manufacturing Inc1,15729%
Hu-Friedy Mfg. Co., Llc76319%
American Eagle Instruments, Inc.2667%
Zoll-Dental2576%
Henry Schein, Inc.2095%
A. Titan Instruments, Inc.1083%
W.H. Holden, Inc.1033%
J & J Instruments Inc1023%

Top labelers

CompanyDevicesShare
Nordent Manufacturing Inc1,15729%
Hu-Friedy Mfg. Co., Llc76319%
American Eagle Instruments, Inc.2667%
Zoll-Dental2576%
Henry Schein, Inc.2095%
A. Titan Instruments, Inc.1083%
W.H. Holden, Inc.1033%
J & J Instruments Inc1023%
Osung Mnd Co., Ltd.972%
Peter Brasseler Holdings, Llc962%
Sklar Corporation812%
Darby Dental Supply, Llc732%

Company = labeler of record on GUDID. 48 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LMDentalNAKOHDENTReicodentdevemedANATOMIC COLOURSERGOPLANTMediconDarby Dental Supply, LLCSCALERBrasseler USAPower Dental USAPower Dental U.S.A., Inc.SCALER D/E CATTONI 104-105 CH HANDLESCALER D/E BUNTING 1-2 CH HANDLESCALER D/E INDIANA 17/18 XL CH HANDLE

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

FDA product codes

CodeNameDevices
EMNSCALER, PERIODONTIC1,745
ELAInstrument, Hand, Calculus Removal1,151
EMNScaler, Periodontic436
EMSCURETTE, PERIODONTIC209
DZNInstruments, Dental Hand181
EMSCurette, Periodontic152

GMDN & GCC registration

  • GMDN code 35320 · non‑implantable
  • Single‑use 5% · sterile 2% · Rx‑only 20% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 179Balloon Length (Inch) · 2Outer Diameter (Millimeter) · 1

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

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

4,008 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Manual dental scaler, reusable", from 48 companies. The largest labeler is Nordent Manufacturing Inc with 29% of records.

Which FDA product codes apply?

EMN (SCALER, PERIODONTIC), ELA (Instrument, Hand, Calculus Removal), EMN (Scaler, Periodontic), EMS (CURETTE, PERIODONTIC)

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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