Identity
- Trade Name
- BURKHART DENTAL FDA UDI
- Generic Name
- Dental amalgam condenser, reusable FDA UDI
- Device Name
- BDS CONDENSER MARQUETTE #1S SERRATED FDA UDI
- Model / Reference
- PLGM0-1S/BH FDA UDI
- Description
- BDS CONDENSER MARQUETTE #1S SERRATED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840018604155 FDA UDI
- FDA Product Code
- EKG FDA UDI
- GMDN Term
- Dental amalgam condenser, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Dental amalgam condenser, reusable
Burkhart Dental by Nordent Manufacturing Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Reicodent — devemed GmbH · Class I
- Reicodent — devemed GmbH · Class I
- Reicodent — devemed GmbH · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nordent Manufacturing Inc
Sources (1)
- FDA UDI d7449174-753d-49fd-8c09-5a17b03e1b04 33 fields · synced May 30, 2026