510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832674Substantially Equivalent

Satelec Prophy Unit Pu 2000S

Spelna, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832674 is the FDA 510(k) clearance record for SATELEC PROPHY UNIT PU 2000S, a class II device, cleared for Spelna, Inc. on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 11 510(k) clearances for Spelna, Inc., from to . As of , FDA records show no recalls naming K832674.

Clearance record

Decision date
Received
(220 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Spelna, Inc. 4221 Richmond Rd., NW, Walker MI
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