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Device Explorer · FDA GUDID · GMDN 35013

Periodontal file/rasp, manual

A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end de

US‑registered devices342in commercial distribution
Companies18labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription23%Rx‑only share
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Share of device records

Hu-Friedy Mfg. Co., Llc15746%
Nordent Manufacturing Inc7221%
Schobell Industrial Ltda237%
Osung Mnd Co., Ltd.144%
Devemed Gmbh124%
Zoll-Dental103%
Ambler Surgical Corp.103%
Peter Brasseler Holdings, Llc93%

Top labelers

CompanyDevicesShare
Hu-Friedy Mfg. Co., Llc15746%
Nordent Manufacturing Inc7221%
Schobell Industrial Ltda237%
Osung Mnd Co., Ltd.144%
Devemed Gmbh124%
Zoll-Dental103%
Ambler Surgical Corp.103%
Peter Brasseler Holdings, Llc93%
W.H. Holden, Inc.62%
Karl Schumacher Dental, Llc51%
Avalign Technologies, Inc.51%
Storz Am Mark Gmbh51%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

KOHDENTReicodentdevemedFILESCALERBrasseler USAPERIO FILE SCHLUGER 9/10 D/E ROUND HANDLEPERIO FILE SUGARMAN 1S/2S D/E HF HANDLEPERIO FILE SUGARMAN 1S/2S D/E HD HANDLEPERIO FILE SUGARMAN 1S/2S D/E CH HANDLEPERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR Karl SchumacherZOLL-DENTALNordent Manufacturing, Inc.BLUE AND GREEN

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

FDA product codes

CodeNameDevices
EMRFile, Periodontic101
EMLCHISEL, BONE, SURGICAL67
EMRFILE, PERIODONTIC56
EJZKNIFE, MARGIN FINISHING, OPERATIVE38
EMKCURETTE, SURGICAL, DENTAL29
EMIFILE, BONE, SURGICAL24

GMDN & GCC registration

  • GMDN code 35013 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 23% · 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 (Inch) · 5

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

How many periodontal file/rasp, manual products are registered in the US?

342 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Periodontal file/rasp, manual", from 18 companies. The largest labeler is Hu-Friedy Mfg. Co., Llc with 46% of records.

Which FDA product codes apply?

EMR (File, Periodontic), EML (CHISEL, BONE, SURGICAL), EMR (FILE, PERIODONTIC), EJZ (KNIFE, MARGIN FINISHING, OPERATIVE)

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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