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EdgePro

FDA UDI

Class II (US FDA UDI)

by Biolase, Inc.

Identity

Trade Name
EdgePro FDA UDI
Generic Name
Dental solid-state laser system FDA UDI
Device Name
A reusable handpiece intended for use with the EdgePro Laser System (Juno) in a variety of dental hard-tissue and soft-tissue procedures. FDA UDI
Model / Reference
EdgePro Handpiece FDA UDI
Description
A reusable handpiece intended for use with the EdgePro Laser System (Juno) in a variety of dental hard-tissue and soft-tissue procedures. FDA UDI

Identifiers

Catalog Number
7220007 FDA UDI
Primary DI / UDI-DI
00647529004241 FDA UDI
510(k) Number
K213428 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
Dental solid-state 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental solid-state laser system

EdgePro by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental solid-state laser system.

Cleared under the same submission

K213428 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biolase, Inc.

Sources (1)

  • FDA UDI 076324bc-07c1-4f50-af58-e71b40b0c651 36 fields · synced May 30, 2026