510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K863243Substantially Equivalent

Shiner Stress Directing Attachment

Js & R - R & D Co., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863243 is the FDA 510(k) clearance record for SHINER STRESS DIRECTING ATTACHMENT, a class I device, cleared for Js & R - R & D Co. on under FDA product code EGG (Attachment, Precision, All). FDA records list one 510(k) clearance for Js & R - R & D Co. As of , FDA records show no recalls naming K863243.

Clearance record

Decision date
Received
(69 days to decision)
Product code
EGG Attachment, Precision, All
Regulation
21 CFR 872.3165
Device class
Class I
Review panel
Dental
Applicant
Js & R - R & D Co. Dental Attachment Systems, 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