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Injectafil A2 Syringe Refill with Tips
FDA UDIClass II (US FDA UDI)
by Vista Dental
Identity
- Trade Name
- Injectafil A2 Syringe Refill with Tips FDA UDI
- Generic Name
- Self-cured dental restorative composite resin FDA UDI
- Device Name
- Injectafil A2 Syringe Refill with Tips FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Injectafil A2 Syringe Refill with Tips FDA UDI
Identifiers
- Catalog Number
- 107-A2-Refill FDA UDI
- Primary DI / UDI-DI
- 00850194007381 FDA UDI
- 510(k) Number
- K091647 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Self-cured dental restorative 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
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
Category: Self-cured dental restorative composite resin
Injectafil A2 Syringe Refill with Tips by Vista Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-cured dental restorative composite resin.
- Build-It FR — KERR CORPORATION · Class II
- Build-It FR — KERR CORPORATION · Class II
- CoreRestore2 — KERR CORPORATION · Class II
- SciPharm Anterior/Posterior Composite Resin Paste/Paste — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- BULK EZ — DANVILLE MATERIALS, LLC · Class II
- Build-It Light Cure — KERR CORPORATION · Class II
- Build-It FR — KERR CORPORATION · Class II
- CoreRestore2 — KERR CORPORATION · Class II
Cleared under the same submission
K091647 also covers:
- Injectafil A2 Syringe with Extrusion Handle — Vista Dental
- Injectafil A4 Syringe Refill with Tips — Vista Dental
- Injectafil A4 Syringe with Extrusion Handle — Vista Dental
- RE-GEN Bulk Fill Composite and Resin Cement A2 Refill — Vista Dental
- RE-GEN Bulk Fill Composite and Resin Cement Kit A2 — Vista Dental
- RE-GEN Bulk Fill Composite and Resin Cement Kit A4 — Vista Dental
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
- Vista Dental
Sources (1)
- FDA UDI 65ae27d9-bbf0-49b2-ab6d-035c56119353 35 fields · synced May 30, 2026