SmileSet Impression Kit

FDA UDI

Class II (US FDA UDI)

by Ortho Dental Lab, Llc

Identity

Trade Name: SmileSet Impression Kit FDA UDI
Generic Name: Dental impression material kit, single-use FDA UDI
Model / Reference: 110-0101 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850078989338 FDA UDI
510(k) Number: K000629 FDA UDI
K092319 FDA UDI
FDA Product Code: ELW 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
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

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental impression material kit, single-use

SmileSet Impression Kit by Ortho Dental Lab, Llc — 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
OrthoFX Home Impression Kit — ORTHOFX · Class II
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

Cleared under the same submission

K000629 also covers:

SDC-impression material (Kulzer) — Access Dental Lab, LLC

K092319 also covers:

SDC impression material (Zest) — Access Dental Lab, LLC

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: Ortho Dental Lab, Llc

Sources (1)

FDA UDI 9266ab74-0738-448b-85a3-2495d0ffaf56 34 fields · synced May 30, 2026