Identity
- Trade Name
- Glidewell™ FDA UDI
- Generic Name
- Dental impression material kit, single-use FDA UDI
- Device Name
- Self Impression Kit FDA UDI
- Model / Reference
- 70-1084-IKT0001 FDA UDI
- Description
- Self Impression Kit FDA UDI
Identifiers
- Catalog Number
- 70-1084-IKT0001 FDA UDI
- Primary DI / UDI-DI
- D745701084IKT00011 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
Glidewell™ by Prismatik Dentalcraft, Inc. — 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
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
- Prismatik Dentalcraft, Inc.
Sources (1)
- FDA UDI a7f57bd7-17d1-40fd-8e05-397cb10923e7 35 fields · synced May 30, 2026