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Biolight

FDA UDI

Class II (US FDA UDI)

by Synca Marketing Inc

Identity

Trade Name
BIOLIGHT FDA UDI
Generic Name
Temporary dental crown/bridge resin FDA UDI
Device Name
BIOLIGHT TEMP CROWN & BRIDGE A2 FDA UDI
Model / Reference
BTM10A2 FDA UDI
Description
BIOLIGHT TEMP CROWN & BRIDGE A2 FDA UDI

Identifiers

Primary DI / UDI-DI
66714700000159 FDA UDI
510(k) Number
K122039 FDA UDI
FDA Product Code
EBG FDA UDI
GMDN Term
Temporary dental crown/bridge resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3770 FDA UDI
Commercial Distribution
Not 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

Dimensions & Sizes

Size
Total Volume — 50 Milliliter FDA UDI

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

Cleared under the same submission

K122039 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 9be7c649-f02a-428c-84ee-96b15b046f2b 38 fields · synced May 31, 2026