K961735 is the FDA 510(k) clearance record for ACTA, a class II device, cleared for Satelec on 1996-07-31 under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 24 510(k) clearances for Satelec, from 1990-11-07 to 2011-12-08 . As of 2026-09-10 , FDA records show no recalls naming K961735.
Clearance record Decision date 1996-07-31 Received 1996-05-03 (89 days to decision) Product code EBZ Activator, Ultraviolet, For PolymerizationRegulation 21 CFR 872.6070 Device class Class II Review panel Dental Applicant Satelec 70 Walnut St., Wellesley MA 510(k) summary Summary Third party review No
Clearances, product code EBZ Trailing 12 months 1 clearance under product code EBZ in the twelve months to October 2026, June 2026 the highest month at 1. Show the numbers FIRST ARTICLE / WEEKLY
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About this record Sourced from the FDA 510(k) premarket notification database, ingested from openFDA. MDM adds the decision time in days, the product code cross-link, recalls sharing that product code, and MDM coverage of the record.
Predicate devices are not listed. The openFDA 510(k) endpoint does not publish predicate references, so MDM does not assert them. Where a 510(k) summary exists, the FDA PDF is linked above and names the predicate itself.
Data as of 2026-09-28 , the FDA export date for this dataset. Page last changed 2026-09-05 . View this record on fda.gov ↗ (opens on fda.gov)
