Identity
- Trade Name
- FAST SPLINT MATRIX FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- ADHESIVE WAX STRIPS FOR 1:4 FIBERS (8-55MM) FDA UDI
- Model / Reference
- FSM14 FDA UDI
- Description
- ADHESIVE WAX STRIPS FOR 1:4 FIBERS (8-55MM) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10667147000200 FDA UDI
- 510(k) Number
- K102207 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
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
Dimensions & Sizes
- Size
- Length — 55 Millimeter FDA UDI
Category: Dental reinforcing fibre
Fast Splint Matrix by Synca Marketing Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental reinforcing fibre.
- GlasSpan Flexible Ceramic Bonding Rope Large Refill — PRACTICON, INC. · Class II
- Infibra — BIOLOREN SRL · Class II
- everStick® — Gc America Inc. · Class II
- everStick® — Gc America Inc. · Class II
- ENFORCE FRC™ — G&H Wire Company, Inc. · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- everStick® — Gc America Inc. · Class II
- Dentapreg® INTRO — ADM, a.s. · Class II
Cleared under the same submission
K102207 also covers:
- CST — Synca Marketing Inc
- CST — Synca Marketing Inc
- CST — Synca Marketing Inc
- CST — Synca Marketing Inc
- FAST SPLINT MATRIX — Synca Marketing Inc
- FAST SPLINT MATRIX — Synca Marketing Inc
- FAST SPLINT MATRIX — Synca Marketing Inc
- FIBER FORCE — Synca Marketing Inc
- FIBER FORCE — Synca Marketing Inc
- FIBER FORCE — Synca Marketing Inc
- FIBER FORCE — Synca Marketing Inc
- FIBER FORCE — Synca Marketing Inc
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
- Synca Marketing Inc
Sources (1)
- FDA UDI 27b95ab3-de5f-454d-9c5d-615ee338953e 37 fields · synced May 31, 2026