510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033705Substantially Equivalent

Bobcat Pro Scaler System, Model G-130

Dentsply International, Inc., York PA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033705 is the FDA 510(k) clearance record for BOBCAT PRO SCALER SYSTEM, MODEL G-130, a class II device, cleared for Dentsply International on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 59 510(k) clearances for Dentsply International, from to . As of , FDA records show no recalls naming K033705.

Clearance record

Decision date
Received
(9 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Dentsply International 570 W. College Ave., York PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELC

Trailing 12 months
2 clearances under product code ELC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ELC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260