510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K972889Substantially Equivalent

Elcomed 100 Types 9925 (W&h- and Innova-Version) and 9927 (Astra-Version), Elcomed 200 Type 9926 (W&h-Version)

W & H Dentalwerk, Burmoos, AT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972889 is the FDA 510(k) clearance record for ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION), a class I device, cleared for W & H Dentalwerk on under FDA product code EBW (Controller, Foot, Handpiece And Cord). FDA records list one 510(k) clearance for W & H Dentalwerk. As of , FDA records show no recalls naming K972889.

Clearance record

Decision date
Received
(170 days to decision)
Product code
EBW Controller, Foot, Handpiece And Cord
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
W & H Dentalwerk Ignaz-Glaser-Strasse 53, Burmoos, AT
510(k) summary
Statement
Third party review
No

Clearances, product code EBW

Trailing 12 months
3 clearances under product code EBW in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EBW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20262
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261