Identity
- Trade Name
- 123-Smile FDA UDI
- Generic Name
- Dental impression material kit, single-use FDA UDI
- Model / Reference
- 12021 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006415488 FDA UDI
- 510(k) Number
- K133071 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression material kit, single-use
123-Smile by U Smile Dental LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression material kit, single-use.
- 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
- Impression Rekit (Small) — STRAIGHT SMILE LLC · Class II
- PEAKOSIL — NEOSIL Co., Ltd · Class II
- SmileSet Impression Kit — ORTHO DENTAL LAB, LLC · Class II
- PEAKOSIL — NEOSIL Co., Ltd · Class II
Cleared under the same submission
K133071 also covers:
- Nobilium — CMP INDUSTRIES LLC
- JMU — JMU DENTAL, INC
- JMU — JMU DENTAL, INC
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
- Elastomeric Impression Material — SHANDONG HUGE DENTAL MATERIAL CORPORATION
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
- U Smile Dental LLC
Sources (1)
- FDA UDI dfa2f7bc-64e9-46e8-9bd4-9d696f146f28 33 fields · synced Jun 1, 2026