510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861561Substantially Equivalent

Zest Mark II (Standard & Mini)

Zest Anchors LLC, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861561 is the FDA 510(k) clearance record for ZEST MARK II (STANDARD & MINI), a class I device, cleared for Zest Anchors, Inc. on under FDA product code EGG (Attachment, Precision, All). FDA records list 26 510(k) clearances for Zest Anchors, Inc., from to . As of , FDA records show no recalls naming K861561.

Clearance record

Decision date
Received
(26 days to decision)
Product code
EGG Attachment, Precision, All
Regulation
21 CFR 872.3165
Device class
Class I
Review panel
Dental
Applicant
Zest Anchors, Inc. 8861 Balboa Ave. Suite B, San Diego CA
Third party review
No

Clearances, product code EGG

Trailing 12 months

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

FDA records show no clearances under product code EGG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EGG, 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