Identity
- Trade Name
- PEAKOSIL FDA UDI
- Generic Name
- Dental impression material kit, single-use FDA UDI
- Device Name
- Product Name: Start Kit This product is a customized Start Kit that one content of the kit was replaced with the other product comparing to the ordinary Start Kit. It includes Light Body 1 EA, Heavy Body 1 EA, Putty 1 EA, Yellow Mix Tip 3 EA, Intra Oral Tip 3 EA & Green Mix Tip 3 EA instead of the contents of ordinary Start Kit(NSSK). FDA UDI
- Model / Reference
- NSSK-1 FDA UDI
- Description
- Product Name: Start Kit This product is a customized Start Kit that one content of the kit was replaced with the other product comparing to the ordinary Start Kit. It includes Light Body 1 EA, Heavy Body 1 EA, Putty 1 EA, Yellow Mix Tip 3 EA, Intra Oral Tip 3 EA & Green Mix Tip 3 EA instead of the contents of ordinary Start Kit(NSSK). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800026400066 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NEOSIL Co., Ltd
Sources (1)
- FDA UDI 9fb7fcbd-3ae1-4176-93cc-78f34bb1ce33 33 fields · synced May 30, 2026