Identity
- Trade Name
- FILLER FDA UDI
- Generic Name
- Dental amalgam condenser, reusable FDA UDI
- Device Name
- NO. 3D FDA UDI
- Model / Reference
- 44-380-22-07 FDA UDI
- Description
- NO. 3D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888118069795 FDA UDI
- FDA Product Code
- GAF FDA UDI
- GMDN Term
- Dental amalgam condenser, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental amalgam condenser, reusable
Filler by KLS-Martin L.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental amalgam condenser, reusable.
- BURKHART DENTAL — NORDENT MANUFACTURING INC · Class I
- Reicodent — devemed GmbH · Class I
- PDT, Inc. — PDT, Inc. · Class I
- Pomee — POMEE CORPORATION · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- OSUNG MND — Osung Mnd Co., Ltd. · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KLS-Martin L.P.
Sources (1)
- FDA UDI eebcbc05-6d54-4f22-9162-e6ab171c1e63 35 fields · synced May 30, 2026