510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942198Substantially Equivalent

Cu-80 Light Cure Unit, Document No. A715676

Rolence Enterprise Co., Ltd., Chungli, Taiwan, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942198 is the FDA 510(k) clearance record for CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676, a class II device, cleared for Rolence Enterprise Co. , Ltd. on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 14 510(k) clearances for Rolence Enterprise Co. , Ltd., from to . As of , FDA records show no recalls naming K942198.

Clearance record

Decision date
Received
(22 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Rolence Enterprise Co. , Ltd. 226 Kong-Shieh-Sir Village, Chungli, Taiwan, TW
510(k) summary
Statement
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
Monthly 510(k) clearances under FDA product code EBZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260