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PDT, Inc. R113 U15-33 Scaler

by PDT, Inc.

Part of a family of 139 devices: see the family page

Ref R113Model Curettes and Scalers

PDT, Inc. R113 U15-33 Scaler is a manual dental scaler (EU MDR Class I; FDA Class I; FDA product code EMN, Scaler, Periodontic) made by PDT, Inc., registered in EUDAMED on 12 May 2026 (Basic UDI-DI 0813677021801WC) and listed in FDA GUDID since 30 Apr 2021 (UDI-DI 00813677020765), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0813677021801WC Basic UDI-DI 00813677020765UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813677020765 UDI-DI Date30 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0813677021801WC registered 12 May 2026 Active
  • FDA GUDID UDI-DI 00813677020765 listed 30 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813677020765
  2. Registered EUDAMED 0813677021801WC

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
U15-33 EUDAMED
PDT, Inc. GUDID
Generic name
Manual dental scaler, reusable
Device name
Hygiene instruments
Model / Ref / Catalog
Curettes and Scalers, R113, R113 U15-33 Scaler
Primary DI / UDI-DI
00813677020765
Basic UDI-DI
0813677021801WC
Direct marketing DI
00813677020765
FDA product code
EMN
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Manual dental scaler, reusable
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Curettes and Scalers
R113
GUDID
R113 U15-33 Scaler

Related devices

Category: Manual dental scaler, reusable

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from PDT, Inc.

See all devices from PDT, Inc. →

Properties

  • Sterilise before use
  • Premarket exempt
Other properties (23, all answered No)