← Back to catalogue
PDT, Inc.
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R007RModel Curettes and Scalers
by PDT, Inc.
Identity
- Trade Name
- Amazing Gracey™ 13-14 Extended Reach Mini Rigid EUDAMEDPDT, Inc. FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Hygiene instruments EUDAMEDGracey 13-14 ER Mini Rigid FDA UDI
- Model / Reference
- Curettes and Scalers EUDAMEDR007R EUDAMEDR007R Gracey 13-14 ER Mini Rigid FDA UDI
- Description
- Gracey 13-14 ER Mini Rigid FDA UDI
Identifiers
- Catalog Number
- R007R FDA UDI
- Primary DI / UDI-DI
- 00813677020123 EUDAMEDFDA UDI
- Basic UDI-DI
- 0813677021801WC EUDAMED
- Direct Marketing DI
- 00813677020123 EUDAMED
- FDA Product Code
- EMS FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Periodontal curette FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Periodontal curette
PDT, Inc. by PDT, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Periodontal curette.
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- CURETTE D/E GR 1-2 REGULAR HD HANDLE — W.H. Holden, Inc. · Class I
- Reicodent — devemed GmbH · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- Power Dental USA — Power Dental USA, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PDT, Inc.
Sources (2)
- FDA UDI 4d03fbd4-0a7b-4e12-8161-9bcc865e5cd4 34 fields · synced Jun 19, 2026
- EUDAMED 09c7bf50-6257-403a-aa9a-073a82ee42cf 61 fields · synced Jun 14, 2026