510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K863676Substantially Equivalent

Genteel

Luben Dental Co., Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863676 is the FDA 510(k) clearance record for GENTEEL, a class II device, cleared for Luben Dental Co., Inc. on under FDA product code ELC (Scaler, Ultrasonic). FDA records list one 510(k) clearance for Luben Dental Co., Inc. As of , FDA records show no recalls naming K863676.

Clearance record

Decision date
Received
(13 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Luben Dental Co., Inc. 521 Fifth Ave., Suite 1740, New York NY
Third party review
No

Clearances, product code ELC

Trailing 12 months
2 clearances under product code ELC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ELC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260