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Fast Splint Matrix

FDA UDI

Class II (US FDA UDI)

by Synca Marketing Inc

Identity

Trade Name
FAST SPLINT MATRIX FDA UDI
Generic Name
Dental material mixing nozzle, sterile 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
66714700001231 FDA UDI
510(k) Number
K102207 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Dental material mixing nozzle, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
Not 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

No

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

Fast Splint Matrix by Synca Marketing Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102207 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synca Marketing Inc

Sources (1)

  • FDA UDI 0d3e7a5e-f021-475b-9724-c042c54a6637 36 fields · synced May 31, 2026