510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K101717Substantially Equivalent

Dental Handpieces, Models: Karam Std/mini; Breeze Std/mini: Karam 45; Dexor 45; Karam 4H Coupling

Aerobine, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101717 is the FDA 510(k) clearance record for DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING, a class I device, cleared for Aerobine, Inc. on under FDA product code EFB (Handpiece, Air-Powered, Dental). FDA records list one 510(k) clearance for Aerobine, Inc. As of , FDA records show no recalls naming K101717.

Clearance record

Decision date
Received
(63 days to decision)
Product code
EFB Handpiece, Air-Powered, Dental
Regulation
21 CFR 872.4200
Device class
Class I
Review panel
Dental
Applicant
Aerobine, Inc. 7670 Opportunity Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
Yes

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