Identity
- Trade Name
- Dental unit FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Model / Reference
- Mare FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974416450008 FDA UDI
- 510(k) Number
- K231845 FDA UDI
- FDA Product Code
- EIA FDA UDI
- GMDN Term
- Dental delivery system instrument unit, electric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental delivery system instrument unit, electric
Dental unit by Foshan Safety Medical Equipment Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental delivery system instrument unit, electric.
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- SCALEX — Dentamerica · Class II
- DCI Edge — DCI International, LLC · Class I
- SCALEX — Dentamerica · Class II
- Standard Triton Self-Contained Delivery Systems — ASI MEDICAL, INC. · Class I
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Foshan Safety Medical Equipment Co., Ltd.
Sources (1)
- FDA UDI 8d9f8314-446b-4884-ae46-42e68acce3fa 33 fields · synced May 30, 2026