510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K802984Substantially Equivalent

Meisinger Diamond Dental Burs

Swiss American Metal Craft Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802984 is the FDA 510(k) clearance record for MEISINGER DIAMOND DENTAL BURS, a class I device, cleared for Swiss American Metal Craft Corp. on under FDA product code DZP (Instrument, Diamond, Dental). FDA records list 4 510(k) clearances for Swiss American Metal Craft Corp. As of , FDA records show no recalls naming K802984.

Clearance record

Decision date
Received
(39 days to decision)
Product code
DZP Instrument, Diamond, Dental
Regulation
21 CFR 872.4535
Device class
Class I
Review panel
Dental
Applicant
Swiss American Metal Craft Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DZP

Trailing 12 months

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

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