Peakosil

FDA UDI

Class II (US FDA UDI)

by NEOSIL Co., Ltd

Identity

Trade Name: PEAKOSIL FDA UDI
Generic Name: Dental impression material kit, single-use FDA UDI
Device Name: Product Name : Teeth impressions kit This product is a convenience kit including One-time Putty 3EA and 6 dental impression trays. The contents of this kit are all registered in FDA. Its content, One-time Putty is a convenience kit that is changed only in packaging materials from Putty(MSP). These changes don't cause any change in the original functions of Putty. Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i). FDA UDI
Model / Reference: NS005P-2 FDA UDI
Description: Product Name : Teeth impressions kit This product is a convenience kit including One-time Putty 3EA and 6 dental impression trays. The contents of this kit are all registered in FDA. Its content, One-time Putty is a convenience kit that is changed only in packaging materials from Putty(MSP). These changes don't cause any change in the original functions of Putty. Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i). FDA UDI

Identifiers

Primary DI / UDI-DI: 08800026400134 FDA UDI
510(k) Number: K152180 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

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

FDA UDI

Category: Dental impression material kit, single-use

Peakosil by NEOSIL Co., Ltd — 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
SmileSet Impression Kit — ORTHO DENTAL LAB, LLC · Class II

Cleared under the same submission

K152180 also covers:

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: NEOSIL Co., Ltd

Sources (1)

FDA UDI b22f0c3c-0c94-41d7-bf6e-e5df45ee9f98 34 fields · synced Jun 8, 2026