Impression Rekit (Large)

FDA UDI

Class II (US FDA UDI)

by Straight Smile Llc

Identity

Trade Name: Impression Rekit (Large) FDA UDI
Generic Name: Dental impression material kit, single-use FDA UDI
Device Name: Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit FDA UDI
Model / Reference: BYTERKL FDA UDI
Description: Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit FDA UDI

Identifiers

Primary DI / UDI-DI: 00850017524057 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental impression material kit, single-use

Impression Rekit (Large) by Straight Smile Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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123-Smile — U Smile Dental LLC · Class II
PEAKOSIL — NEOSIL Co., Ltd · Class II
SmileSet Impression Kit — ORTHO DENTAL LAB, LLC · Class II
PEAKOSIL — NEOSIL Co., Ltd · 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: Straight Smile Llc

Sources (1)

FDA UDI 4731bdf2-beb7-4120-8c6b-2bd7e3cdee31 34 fields · synced Jun 8, 2026