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PDT, Inc.
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref R138TModel Curettes and Scalers
by PDT, Inc.
Identity
- Trade Name
- Montana Jack® B-Ti (Blunt Titanium) EUDAMEDPDT, Inc. FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Hygiene instruments EUDAMEDMontana Jack Blunt Titanium FDA UDI
- Model / Reference
- Curettes and Scalers EUDAMEDR138T EUDAMEDR138T Montana Jack Blunt Titanium FDA UDI
- Description
- Montana Jack Blunt Titanium FDA UDI
Identifiers
- Catalog Number
- R138T FDA UDI
- Primary DI / UDI-DI
- 00813677020956 EUDAMEDFDA UDI
- Basic UDI-DI
- 0813677021801WC EUDAMED
- Direct Marketing DI
- 00813677020956 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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Also classified as Manual dental scaler, reusable.
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- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
- Pomee — POMEE CORPORATION · 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 |
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Manufacturer
- Manufacturer
- PDT, Inc.
Sources (2)
- FDA UDI 41565e3e-cc6e-45e8-b807-a96662fde0a8 34 fields · synced Jul 11, 2026
- EUDAMED a1f378d7-fb59-4fcb-95e0-3d436fce6724 61 fields · synced Jul 11, 2026