510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K833038Substantially Equivalent

Summa Disk

Shofu Dental Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833038 is the FDA 510(k) clearance record for SUMMA DISK, a class I device, cleared for Shofu Dental Corp. on under FDA product code DZP (Instrument, Diamond, Dental). FDA records list 97 510(k) clearances for Shofu Dental Corp., from to . As of , FDA records show no recalls naming K833038.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DZP Instrument, Diamond, Dental
Regulation
21 CFR 872.4535
Device class
Class I
Review panel
Dental
Applicant
Shofu Dental 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