Identity
- Trade Name
- SCALEX FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- Ultrasonic Scaler FDA UDI
- Model / Reference
- 890 FDA UDI
- Description
- Ultrasonic Scaler FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858466005141 FDA UDI
- 510(k) Number
- K954820 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental delivery system instrument unit, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system instrument unit, electric
Scalex by Dentamerica — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K954820 also covers:
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
- Dentamerica
Sources (1)
- FDA UDI afed5735-a0a5-4e51-b766-8d9669e17d9a 34 fields · synced May 30, 2026