Identity
- Trade Name
- Lynx Scalemaster FDA UDI
- Generic Name
- Rotary dental scaler FDA UDI
- Device Name
- The Lynx Scalemaster is an ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an sonic vibrating scaler tip to the teeth. FDA UDI
- Model / Reference
- LX3004H02 FDA UDI
- Description
- The Lynx Scalemaster is an ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an sonic vibrating scaler tip to the teeth. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D826LX3004H021 FDA UDI
- 510(k) Number
- K901488 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Rotary dental scaler FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Lynx Scalemaster by Mti Precision Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Mti Precision Products
Sources (1)
- FDA UDI 72f3699d-e23e-42c9-966f-a947e22f4635 35 fields · synced May 30, 2026