510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812360Substantially Equivalent

Precious-Metal/plastic Attach., Auxill

Zl-Microdent-Attachments, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812360 is the FDA 510(k) clearance record for PRECIOUS-METAL/PLASTIC ATTACH., AUXILL, a class I device, cleared for Zl-Microdent-Attachments on under FDA product code EGG (Attachment, Precision, All). FDA records list one 510(k) clearance for Zl-Microdent-Attachments. As of , FDA records show no recalls naming K812360.

Clearance record

Decision date
Received
(32 days to decision)
Product code
EGG Attachment, Precision, All
Regulation
21 CFR 872.3165
Device class
Class I
Review panel
Dental
Applicant
Zl-Microdent-Attachments 803 N. Front St. Suite 3, Mchenry IL
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