Identity
- Trade Name
- Harvard PremiumFlow OptiTips A1 FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Flowable light cure nano-hybrid composite for restorations FDA UDI
- Model / Reference
- 7083623 FDA UDI
- Description
- Flowable light cure nano-hybrid composite for restorations FDA UDI
Identifiers
- Primary DI / UDI-DI
- EHAR70836231 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Category: Dental composite resin
Harvard PremiumFlow OptiTips A1 by Harvard Dental International GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Harvard Dental International GmbH
Sources (1)
- FDA UDI 2deea73f-bda5-432c-a3ca-0479a5f19024 35 fields · synced Jun 8, 2026