510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K782007Substantially Equivalent

Rotary Scaler

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

K782007 is the FDA 510(k) clearance record for ROTARY SCALER, a class II device, cleared for Star Dental Mfg. Co. on under FDA product code ELB (Scaler, Rotary). FDA records list 5 510(k) clearances for Star Dental Mfg. Co., from to . As of , FDA records show no recalls naming K782007.

Clearance record

Decision date
Received
(33 days to decision)
Product code
ELB Scaler, Rotary
Regulation
21 CFR 872.4840
Device class
Class II
Review panel
Dental
Applicant
Star Dental Mfg. Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code ELB

Trailing 12 months

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

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