510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830116Substantially Equivalent

Sulcarings

North Pacific Dental, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830116 is the FDA 510(k) clearance record for SULCARINGS, a class I device, cleared for North Pacific Dental, Inc. on under FDA product code EIF (Accessories, Retractor, Dental). FDA records list 11 510(k) clearances for North Pacific Dental, Inc., from to . As of , FDA records show no recalls naming K830116.

Clearance record

Decision date
Received
(38 days to decision)
Product code
EIF Accessories, Retractor, Dental
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
North Pacific Dental, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EIF

Trailing 12 months

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

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