PDT, Inc. R904 PDT3SAVER™ 2
by PDT, Inc.
Ref R904
PDT, Inc. R904 PDT3SAVER 2 is a manual dental scaler (EU MDR Class I; FDA Class I) made by PDT, Inc., registered in EUDAMED on 14 May 2026 (Basic UDI-DI 0813677021807WQ) and listed in FDA GUDID since 26 Jun 2024 (UDI-DI 00813677024800), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0813677021807WQ 00813677024800 | Date14 May 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00813677024800 | Date26 Jun 2024 | StatusListed |
Official records
- EUDAMED public site 0813677021807WQ
- AccessGUDID record 00813677024800
Across registries
- EUDAMED Basic UDI-DI 0813677021807WQ registered 14 May 2026 Active
- FDA GUDID UDI-DI 00813677024800 listed 26 Jun 2024 Listed
Timeline
- Listed FDA GUDID 00813677024800
- Registered EUDAMED 0813677021807WQ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- PDT3SAVER™ w/ Columbia 13-14, H5-L5 Mini, and Montana Jack® EUDAMEDPDT, Inc. GUDID
- Generic name
- Manual dental scaler, reusable
- Device name
- Hygiene instrument kits
- Model / Ref / Catalog
- R904, R904 PDT3SAVER™ 2
- Description
- Set Includes: R064 Columbia 13-14 R092 H5-L5 Mini R138 Montana Jack®
- Primary DI / UDI-DI
- 00813677024800
- Basic UDI-DI
- 0813677021807WQ
- FDA product code
- EMN, EMS
- EMDN code
- Q010399 Surgical dental devices - other
- GMDN term
- Manual dental scaler, reusable
- Device class
- Class I
- Regulation number
- 872.4565
- System or procedure pack
- Procedure pack
- EU registration type
- System or procedure pack
- Medical purpose
- Dental curettes/scalers for periodontal hygiene
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | R904 | R904 PDT3SAVER™ 2 |
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