R7 Ultrasonic Scaler
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by CEFLA s.c.
Identity
- Trade Name
- R7 EUDAMED
- Model / Reference
- Dental Units EUDAMED71R90000 EUDAMED71R70000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033837937463 EUDAMED08033837933298 EUDAMED
- Basic UDI-DI
- 803383793TRDENTUNA001QY EUDAMED
- Direct Marketing DI
- 08033837937463 EUDAMED08033837933298 EUDAMED
- 510(k) Number
- K130834 FDA 510(k)
- FDA Product Code
- ELC FDA 510(k)
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4850 FDA 510(k)
- Regulation Number
- 872.4850 FDA 510(k)
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The R7 Ultrasonic Scaler is a Class II dental device designed for ultrasonic scaling in periodontal and restorative dentistry. It employs high-frequency vibrations to remove plaque, calculus, and biofilm from teeth surfaces, aiding in periodontal therapy and oral hygiene maintenance.
This device is supplied as a reusable, non-sterile instrument intended for use in dental clinics. It operates within standard dental office environments and requires no special storage conditions beyond manufacturer guidelines. Authorized under FDA 510(k) clearance and MDR compliance, the R7 is categorized under regulation number 872.4850 for dental ultrasonic scalers.
Frequently asked questions
What is the primary purpose of the R7 Ultrasonic Scaler in dental procedures?
The R7 Ultrasonic Scaler is designed specifically for ultrasonic scaling in dental treatments, particularly in periodontal and restorative dentistry. It uses high-frequency vibrations to efficiently remove plaque, calculus, and biofilm from tooth surfaces, helping to maintain oral hygiene and support periodontal therapy.
Is the R7 Ultrasonic Scaler intended for single-use or reusable applications?
The R7 Ultrasonic Scaler is supplied as a reusable instrument, meaning it is meant to be used repeatedly in dental clinics after proper cleaning and maintenance. It is not intended for single-use and is classified as non-sterile, so it must be handled according to standard dental office disinfection protocols.
What storage conditions are required for the R7 Ultrasonic Scaler?
The R7 Ultrasonic Scaler does not require any special storage conditions beyond those recommended by the manufacturer. It is designed for use in standard dental office environments, so typical clinic storage practices should suffice, provided they comply with the manufacturer’s guidelines.
How is the regulatory compliance of the R7 Ultrasonic Scaler established?
The R7 Ultrasonic Scaler holds both FDA 510(k) clearance and MDR compliance, indicating it meets regulatory standards for safety and effectiveness in the United States and European markets. It is categorized under FDA regulation number 872.4850 for dental ultrasonic scalers, with a traditional clearance process through the Dental Advisory Committee.
Are there different models or sizes available for the R7 Ultrasonic Scaler?
The provided data does not specify distinct models or sizes for the R7 Ultrasonic Scaler, but it is categorized under product code ELC for dental ultrasonic scalers. For specific variations, such as handpiece attachments or power settings, you would need to refer to the manufacturer’s documentation or contact CEFLA directly.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dentist Chair | Anthos R7 Dental Chair Unit - Cefla Medical, Anthos | R7 & Linea Cabinetry | Cefla North America, Anthos R7 | Cefla North America | DPS, Cefla Anthos R7 with Scaler | Patterson Overstock
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K130834 | Class II | Active |
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Manufacturer
- Manufacturer
- CEFLA s.c.
Sources (3)
- FDA 510(k) K130834 24 fields · synced Sep 18, 2026
- EUDAMED da35175b-4c0a-4d8a-8764-a38b615e1acb 61 fields · synced Jul 15, 2026
- EUDAMED 505e56d6-eb57-4fd9-a9d8-f9f227473a4c 61 fields · synced Jul 31, 2026