Identity
- Trade Name
- Signum composite FDA UDI
- Generic Name
- Dental prosthesis veneer resin FDA UDI
- Device Name
- Signum composite dentine, DD2, 4 g FDA UDI
- Model / Reference
- 66020019 FDA UDI
- Description
- Signum composite dentine, DD2, 4 g FDA UDI
Identifiers
- Catalog Number
- 66020019 FDA UDI
- Primary DI / UDI-DI
- J014660200190 FDA UDI
- 510(k) Number
- K240660 FDA UDI
- FDA Product Code
- EBF FDA UDIEBD FDA UDI
- GMDN Term
- Dental prosthesis veneer resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3310 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental prosthesis veneer resin
Signum composite by Kulzer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental prosthesis veneer resin.
- Defend — Young Innovations, Inc. · Class II
- Ceramage — SHOFU DENTAL CORP. · Class II
- CERAMAGE — SHOFU DENTAL CORP. · Class II
- Ceramill — Vertex-Dental B.V. · Class I
- Solidex — SHOFU DENTAL CORP. · Class II
- Universal Opaque — SHOFU DENTAL CORP. · Class II
- Universal Opaque — SHOFU DENTAL CORP. · Class II
- VITAVM LC — Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft · Class II
Cleared under the same submission
K240660 also covers:
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
- Signum composite — Kulzer, Inc.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Kulzer, Inc.
Sources (1)
- FDA UDI 8695633f-474c-4ecc-a1be-1d39adaa940b 36 fields · synced May 30, 2026