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PDT, Inc.
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R028DModel Curettes and Scalers
by PDT, Inc.
Identity
- Trade Name
- Amazing Gracey™ 13-14 DULL EUDAMEDPDT, Inc. FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Hygiene instruments EUDAMEDR028D Amazing Gracey 13-14 DULL FDA UDI
- Model / Reference
- Curettes and Scalers EUDAMEDR028D EUDAMEDR028D Amazing Gracey 13-14 DULL FDA UDI
- Description
- R028D Amazing Gracey 13-14 DULL FDA UDI
Identifiers
- Catalog Number
- R028D FDA UDI
- Primary DI / UDI-DI
- 00813677024664 EUDAMEDFDA UDI
- Basic UDI-DI
- 0813677021801WC EUDAMED
- Direct Marketing DI
- 00813677024664 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Periodontal curette
PDT, Inc. by PDT, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- PDT, Inc.
Sources (2)
- FDA UDI b9581536-ac92-4a22-b89a-6710b7f1e508 34 fields · synced Jun 19, 2026
- EUDAMED f3aa04c2-16fc-4659-8466-0a3912959ed9 61 fields · synced Jun 19, 2026