510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801483Substantially Equivalent

Mark IV Syringe

National Patent Development Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801483 is the FDA 510(k) clearance record for MARK IV SYRINGE, a class I device, cleared for National Patent Development Corp. on under FDA product code EIC (Syringe, Periodontic, Endodontic, Irrigating). FDA records list 34 510(k) clearances for National Patent Development Corp., from to . As of , FDA records show no recalls naming K801483.

Clearance record

Decision date
Received
(66 days to decision)
Product code
EIC Syringe, Periodontic, Endodontic, Irrigating
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
National Patent Development Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EIC

Trailing 12 months

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

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