Identity
- Trade Name
- SmartByte Palatal Impression Kit FDA UDI
- Generic Name
- Dental impression material kit, single-use FDA UDI
- Device Name
- Single-use impression kit for taking VPS impression of patient's palate and upper and lower arches including all upper and lower teeth FDA UDI
- Model / Reference
- SI-004.01 FDA UDI
- Description
- Single-use impression kit for taking VPS impression of patient's palate and upper and lower arches including all upper and lower teeth FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001615319 FDA UDI
- GMDN Term
- Dental impression material kit, single-use FDA UDI
Classification
- 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental impression material kit, single-use
SmartByte Palatal Impression Kit by Scientific Intake — 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
- 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
- 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Scientific Intake
Sources (1)
- FDA UDI f0d25913-6c63-4fe0-8302-a18ed28104b4 33 fields · synced May 30, 2026