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Sonus M4 M 4

by Engler Engineering Corp. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862872000324 UDI-DIDate4 May 2021ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Sonus M4
Generic Name
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Model / Ref / Catalog
M 4, 133-1204
Primary DI / UDI-DI
00862872000324
510(k) Number
FDA Product Code
ELC
GMDN Term
Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Device Class
Class II
Regulation Number
872.4850
GUDID distribution status
In Commercial Distribution
Sterilization Method
Dry Heat Sterilization
MRI Safety
MR Unsafe
Size
Length — 1.9 Inch
Width — .25 Inch

Related devices

Category: Ultrasonic dental scaling/debridement system handpiece tip, periodontal

Cleared under the same submission (K811396)

Other devices from Engler Engineering Corp.

See all devices from Engler Engineering Corp. →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No