510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841005Substantially Equivalent

Tonsil Knife-Various

Premier Dental Products Co, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841005 is the FDA 510(k) clearance record for TONSIL KNIFE-VARIOUS, a class I device, cleared for Premier Dental Products Co. on under FDA product code KBQ (Knife, Tonsil). FDA records list 44 510(k) clearances for Premier Dental Products Co., from to . As of , FDA records show no recalls naming K841005.

Clearance record

Decision date
Received
(82 days to decision)
Product code
KBQ Knife, Tonsil
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Premier Dental Products Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KBQ

Trailing 12 months

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

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