Galaxy

FDA UDI

Class I (US FDA UDI)

by Ortho Technology, Inc.

Identity

Trade Name: Galaxy FDA UDI
Generic Name: Interproximal dental gauge, reusable FDA UDI
Device Name: Galaxy Interproximal Reduction 6pc Gauge Set FDA UDI
Model / Reference: IPR-GAUGE FDA UDI
Description: Galaxy Interproximal Reduction 6pc Gauge Set FDA UDI

Identifiers

Primary DI / UDI-DI: 00190730030702 FDA UDI
FDA Product Code: EIL FDA UDI
GMDN Term: Interproximal dental gauge, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Interproximal dental gauge, reusable

Galaxy by Ortho Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Henry Schein — HENRY SCHEIN, INC. · Class I
ZOLL-DENTAL — Zoll-Dental · Class I
HU-FRIEDY — HU-FRIEDY MFG CO., LLC · Class I
DENTECH — Dentech Corp. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Ortho Technology, Inc.

Sources (1)

FDA UDI c4a8ca66-2d3f-4ce5-a998-0342f3e98852 33 fields · synced Jun 8, 2026