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Sl3®

FDA UDI

Class II (US FDA UDI)

by Den-Mat Holdings, LLC

Identity

Trade Name
SL3® FDA UDI
Generic Name
Dental diode laser system FDA UDI
Device Name
FIBERS AC-FIBER 400um 12FT FDA UDI
Model / Reference
ZLR1018 FDA UDI
Description
FIBERS AC-FIBER 400um 12FT FDA UDI

Identifiers

Catalog Number
ZLR1018 FDA UDI
Primary DI / UDI-DI
D813ZLR10180 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Dental diode laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental diode laser system

Sl3® by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental diode laser system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI b7f8f9fd-3bf7-4262-ab0f-306d36427250 35 fields · synced Jun 9, 2026