Relacs 7000

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K951272 ↗

FDA Product Code

ELC

Device Class

Class II

Regulation

21 CFR Part 872.4850

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Series Xe, Series Se, Series Te

  Class I

  FDA 510(k) K971350 Active Cleared 4 Jun 1997

• Ax's Endo 04, 06, 08, 2.5, 40, Models 50100206, 50100217, 50100218, 50100230, 50100232

  Class I

  FDA 510(k) K042171 Active Cleared 10 Nov 2004

• Sonic Air MM1500 + (Mid), Model 50400014

  Class II

  FDA 510(k) K081268 Active Cleared 10 Aug 2009

• Mm 324

  Class I

  FDA 510(k) K961076 Active Cleared 26 Apr 1996

• Sirius 180, 180l, 230, 230l

  Class I

  FDA 510(k) K961235 Active Cleared 8 Jan 1997

• Apex Pointer+; Measruing Cable, Hook, Lip Clip, Touch Probe (Accessories)

  Unclassified

  FDA 510(k) K103123 Active Cleared 10 Mar 2011

See all devices from Micro-Mega Societe Anonyme →

• Is the Relacs 7000 designed for single-use or reusable applications in a dental setting?

  The Relacs 7000 is explicitly described as a reusable instrument for dental use. Since it is intended for professional dental cleaning procedures, it must be properly cleaned, disinfected, and maintained between uses in accordance with dental office protocols.

• What regulatory pathway was followed for the FDA clearance of the Relacs 7000?

  The Relacs 7000 received FDA 510(k) clearance (K951272) under the Traditional 510(k) pathway, classified as a Class II device under regulation 872.4850. The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device.

• Are there any specific storage requirements mentioned for the Relacs 7000?

  The provided data does not explicitly detail storage requirements for the Relacs 7000. However, as a reusable dental ultrasonic scaler, it should be stored in a clean, dry environment, protected from moisture and contamination, following standard dental instrument maintenance guidelines.

• What types of dental debris does the Relacs 7000 remove during professional cleaning?

  The Relacs 7000 uses ultrasonic energy to efficiently remove plaque, calculus (tartar), and stains from tooth surfaces during professional dental cleanings. It is specifically designed for scaling procedures in dental offices and clinics.