510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921571Substantially Equivalent

1St Impression

Wykle Research, Inc., Carson City NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921571 is the FDA 510(k) clearance record for 1ST IMPRESSION, a class II device, cleared for Wykle Research, Inc. on under FDA product code ELW (Material, Impression). FDA records list 3 510(k) clearances for Wykle Research, Inc., from to . As of , FDA records show no recalls naming K921571.

Clearance record

Decision date
Received
(526 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Wykle Research, Inc. 2222 Hot Springs Rd., Carson City NV
510(k) summary
Summary
Third party review
No

Clearances, product code ELW

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