510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895283Substantially Equivalent

Prosthetic Restoration Device

Swiss Precision Mfg. Corp., Bayshore NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895283 is the FDA 510(k) clearance record for PROSTHETIC RESTORATION DEVICE, a class I device, cleared for Swiss Precision Mfg. Corp. on under FDA product code EBL (Pin, Retentive And Splinting, And Accessory Instruments). FDA records list one 510(k) clearance for Swiss Precision Mfg. Corp. As of , FDA records show no recalls naming K895283.

Clearance record

Decision date
Received
(174 days to decision)
Product code
EBL Pin, Retentive And Splinting, And Accessory Instruments
Regulation
21 CFR 872.3740
Device class
Class I
Review panel
Dental
Applicant
Swiss Precision Mfg. Corp. 66 (E) S. Second St., Bayshore NY
Third party review
No

Clearances, product code EBL

Trailing 12 months

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

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