510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K912786Substantially Equivalent

W-H Topair Dental Handpiece

Sabra-The Dental Products Group, Skokie IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912786 is the FDA 510(k) clearance record for W-H TOPAIR DENTAL HANDPIECE, a class I device, cleared for Sabra-The Dental Products Group on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list one 510(k) clearance for Sabra-The Dental Products Group. As of , FDA records show no recalls naming K912786.

Clearance record

Decision date
Received
(23 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Sabra-The Dental Products Group 7642 N. Kolmar Ave., Skokie IL
510(k) summary
Statement
Third party review
No

Clearances, product code EFB

Trailing 12 months
4 clearances under product code EFB 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 EFB, 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 20261
October 20261