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PDT, Inc.
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R113Model Curettes and Scalers
by PDT, Inc.
Identity
- Trade Name
- U15-33 EUDAMEDPDT, Inc. FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Hygiene instruments EUDAMEDU15-33 Scaler FDA UDI
- Model / Reference
- Curettes and Scalers EUDAMEDR113 EUDAMEDR113 U15-33 Scaler FDA UDI
- Description
- U15-33 Scaler FDA UDI
Identifiers
- Catalog Number
- R113 FDA UDI
- Primary DI / UDI-DI
- 00813677020765 EUDAMEDFDA UDI
- Basic UDI-DI
- 0813677021801WC EUDAMED
- Direct Marketing DI
- 00813677020765 EUDAMED
- FDA Product Code
- EMN FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Manual dental scaler, reusable 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: Manual dental scaler, reusable
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 2c438ec5-b7de-443e-8df4-34937b75fe94 34 fields · synced Jul 16, 2026
- EUDAMED 61aa5521-7c33-4c7a-900a-7d91189f670a 61 fields · synced Jul 16, 2026