Identity
- Trade Name
- TheraCem Ca FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- THERACEM Ca 1G DUAL SYR SAMPLE FDA UDI
- Model / Reference
- D-46502S FDA UDI
- Description
- THERACEM Ca 1G DUAL SYR SAMPLE FDA UDI
Identifiers
- Catalog Number
- D-46502S FDA UDI
- Primary DI / UDI-DI
- 00810111541329 FDA UDI
- 510(k) Number
- K161256 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
No
FDA UDI
MR Safe FDA UDI
Category: Dental composite resin
TheraCem Ca by Bisco Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
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- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K161256 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bisco Inc.
Sources (1)
- FDA UDI 1d48a5a3-6a8e-47fa-89bb-fe09ca6367f3 37 fields · synced May 30, 2026