510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855167Substantially Equivalent

Dyna System

Parker Laboratories, Inc., Farmingdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855167 is the FDA 510(k) clearance record for DYNA SYSTEM, a class I device, cleared for Parker Laboratories, Inc. on under FDA product code EGG (Attachment, Precision, All). FDA records list 30 510(k) clearances for Parker Laboratories, Inc., from to . As of , FDA records show no recalls naming K855167.

Clearance record

Decision date
Received
(68 days to decision)
Product code
EGG Attachment, Precision, All
Regulation
21 CFR 872.3165
Device class
Class I
Review panel
Dental
Applicant
Parker Laboratories, Inc. 155 Schmitt Blvd., Farmingdale NY
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