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R7 Ultrasonic Scaler

by CEFLA s.c.

Part of a family of 119 devices: see the family page

510(k) K130834Ref 71R90000, 71R70000Model Dental Units

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130834↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803383793TRDENTUNA001QY Basic UDI-DI Date14 Oct 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK130834 Date8 Oct 2013ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 803383793TRDENTUNA001QY registered 14 Oct 2025 Active
  • FDA 510(k) K130834 decided 8 Oct 2013 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K130834
  2. Registered EUDAMED 803383793TRDENTUNA001QY

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
R7
Model / reference
Dental Units, 71R90000, 71R70000
Primary DI / UDI-DI
08033837937463, 08033837933298
Basic UDI-DI
803383793TRDENTUNA001QY
Direct marketing DI
08033837937463
08033837933298
510(k) Number
FDA product code
ELC
EMDN code
Z12110101 Dental treatment units
Device class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 872.4850
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Italy
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIa
510(k)
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices in this category

Other devices filed under DENTAL TREATMENT UNITS.

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Properties

Other properties (14, all answered No)