Identity
- Trade Name
- FAST SPLINT MATRIX FDA UDI
- Generic Name
- Dental material mixing nozzle FDA UDI
- Device Name
- SILICONE WIDE APPLICATION TIPS (100) FDA UDI
- Model / Reference
- FSM18 FDA UDI
- Description
- SILICONE WIDE APPLICATION TIPS (100) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10667147000224 FDA UDI
- 510(k) Number
- K102207 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental material mixing nozzle 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material mixing nozzle
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 material mixing nozzle.
- Adhesive Tip Applicator — Huanghua Promisee Dental Co.Ltd. · Class I
- 3.2 Mixing Tips with Integrated Needle 25-Pack — Den-Mat Holdings, LLC · Class I
- RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Imprint™ 4 Regular — 3M Deutschland GmbH · Class II
- Cling2®/Temptation® Now 1:1 Mixing Tips — CLINICIAN'S CHOICE DENTAL PRODUCTS, INC. · Class I
- #1031-EU — Kuraray Noritake Dental Inc. Kurashiki · Class I
- Plasdent — PLASDENT CORP. · Class I
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 bbc45ee0-680b-4a2b-ad81-3cb0c70363cb 35 fields · synced Jun 6, 2026