Identity
- Trade Name
- SCOTT'S SELECT DELUXE SONIC SCALER 4-LINE FDA UDI
- Generic Name
- Pneumatic dental scaling/debridement system handpiece FDA UDI
- Device Name
- SONIC SCALER (1/pack) Contains: 1 deluxe sonic scaler, 1 universal tip and tip wrench; For more information: https://www.scottsdental.com/deluxe-sonic-scaler-scott-s-select.html FDA UDI
- Model / Reference
- 135-5400 FDA UDI
- Description
- SONIC SCALER (1/pack) Contains: 1 deluxe sonic scaler, 1 universal tip and tip wrench; For more information: https://www.scottsdental.com/deluxe-sonic-scaler-scott-s-select.html FDA UDI
Identifiers
- Catalog Number
- 135-5400 FDA UDI
- Primary DI / UDI-DI
- D77813554000 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Pneumatic dental scaling/debridement system handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Pneumatic dental scaling/debridement system handpiece
Scott's Select Deluxe Sonic Scaler 4-Line by Scott's Dental Supply L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Scott's Dental Supply L.l.c.
Sources (1)
- FDA UDI b558f073-7838-4f42-85a4-2ac5d169d698 35 fields · synced May 30, 2026