510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971002Substantially Equivalent

Smile with Confidence

Lloyd V. Ziemendorf, Niagara Falls NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971002 is the FDA 510(k) clearance record for SMILE WITH CONFIDENCE, a class II device, cleared for Lloyd V. Ziemendorf on under FDA product code EHS (Cushion, Denture, Over The Counter). FDA records list one 510(k) clearance for Lloyd V. Ziemendorf. As of , FDA records show no recalls naming K971002.

Clearance record

Decision date
Received
(118 days to decision)
Product code
EHS Cushion, Denture, Over The Counter
Regulation
21 CFR 872.3540
Device class
Class II
Review panel
Dental
Applicant
Lloyd V. Ziemendorf 6762 Ward Rd., Niagara Falls NY
510(k) summary
Statement
Third party review
No

Clearances, product code EHS

Trailing 12 months

FDA records hold no clearances under product code EHS in the trailing twelve months.

FDA records show no clearances under product code EHS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EHS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260