OrthoFX Home Impression Kit

FDA UDI

Class II (US FDA UDI)

by Orthofx

Identity

Trade Name: OrthoFX Home Impression Kit FDA UDI
Generic Name: Dental impression material kit, single-use FDA UDI
Device Name: Revise Home Impression Kit UDI (PVS version) FDA UDI
Model / Reference: HIK1-rev FDA UDI
Description: Revise Home Impression Kit UDI (PVS version) FDA UDI

Identifiers

Primary DI / UDI-DI: 00860003321744 FDA UDI
FDA Product Code: ELW FDA UDI
EHY FDA UDI
GMDN Term: Dental impression material kit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3660 FDA UDI
872.6880 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental impression material kit, single-use

OrthoFX Home Impression Kit by Orthofx — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental impression material kit, single-use.

123-Smile — U Smile Dental LLC · Class II
SmartByte Palatal Impression Kit — Scientific Intake
TEMREX BITE RELATOR — Temrex Corp. · Class I
Impression Rekit (Large) — STRAIGHT SMILE LLC · Class II
123-Smile — U Smile Dental LLC · Class II
Impression Rekit (Small) — STRAIGHT SMILE LLC · Class II
PEAKOSIL — NEOSIL Co., Ltd · Class II
SmileSet Impression Kit — ORTHO DENTAL LAB, LLC · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Orthofx

Sources (1)

FDA UDI 79f3d880-326a-4740-8ce9-c65a17f25444 34 fields · synced Jun 8, 2026