Identity
- Trade Name
- everStick® FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- everStick® NET 1 x 30 cm2 fiber mesh FDA UDI
- Model / Reference
- 900818 FDA UDI
- Description
- everStick® NET 1 x 30 cm2 fiber mesh FDA UDI
Identifiers
- Catalog Number
- 900818 FDA UDI
- Primary DI / UDI-DI
- 15400556008550 FDA UDI
- 510(k) Number
- K011799 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental reinforcing fibre FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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: Dental reinforcing fibre
everStick® by Gc America Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K011799 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
- Gc America Inc.
Sources (1)
- FDA UDI f86b7906-6d37-4ae7-a8d2-00c168e2f346 37 fields · synced Jun 8, 2026