Identity
- Trade Name
- Bosworth SuperEBA FDA UDI
- Generic Name
- Ethoxy benzoic acid dental cement FDA UDI
- Device Name
- 15 g Pwd & 6.5 ml Liq Cement Combo Kit, Fast & Reg. Set FDA UDI
- Model / Reference
- 0921007 FDA UDI
- Description
- 15 g Pwd & 6.5 ml Liq Cement Combo Kit, Fast & Reg. Set FDA UDI
Identifiers
- Catalog Number
- 0921007 FDA UDI
- Primary DI / UDI-DI
- H66809210071 FDA UDI
- 510(k) Number
- K983752 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Ethoxy benzoic acid dental cement 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
Yes
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
Category: Ethoxy benzoic acid dental cement
Bosworth SuperEBA by Harry J. Bosworth Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ethoxy benzoic acid dental cement.
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- BISICO Cementime DC — bisico Bielefelder Dentalsilicone GmbH & Co. KG · Class II
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- DiaCemTempNE — DiaDent Group International · Class I
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Cleared under the same submission
K983752 also covers:
- Bosworth SuperEBA — Harry J. Bosworth Co.
- Bosworth SuperEBA — Harry J. Bosworth Co.
- Bosworth SuperEBA — Harry J. Bosworth Co.
- Bosworth SuperEBA — Harry J. Bosworth Co.
- Bosworth SuperEBA — Harry J. Bosworth Co.
- Bosworth SuperEBA — Harry J. Bosworth Co.
- Bosworth SuperEBA — Harry J. Bosworth Co.
- Bosworth SuperEBA — Harry J. Bosworth Co.
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
- Harry J. Bosworth Co.
Sources (1)
- FDA UDI 5e2831a5-15bf-4987-bab0-fc9495d4d464 37 fields · synced May 30, 2026