Rolence Enterprise Co. , Ltd. is one of 203 FDA 510(k) medical device manufacturers from Taiwan in the dataset, ranked by real submission volume.
Rolence Enterprise Co. , Ltd. - FDA 510(k) Cleared Devices
12
Total
12
Cleared
0
Denied
Rolence Enterprise Co. , Ltd. has 12 FDA 510(k) cleared dental devices. Based in Chungli, Taiwan, TW.
Historical record: 12 cleared submissions from 1993 to 2000.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Rolence Enterprise Co. , Ltd.
12 devices
Cleared
Oct 10, 2000
Q-LUX PLASMA 100 LIGHT CURE UNIT
Dental
127d
Cleared
Jul 20, 1999
Q-LITE 75 LIGHT CURE UNIT
Dental
49d
Cleared
Jul 19, 1999
CUTE-LITE I LIGHT CURE UNIT
Dental
48d
Cleared
May 15, 1998
CU-100A LIGHT CURE UNIT
Dental
74d
Cleared
May 15, 1998
Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
Dental
74d
Cleared
Apr 15, 1996
Q-LUX LIGHT CURE UNIT
Dental
81d
Cleared
Apr 15, 1996
CU-200 LIGHT CURE UNIT
Dental
81d
Cleared
Sep 29, 1995
PROPHY ANGLE
Dental
60d
Cleared
Jun 22, 1995
CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676
Dental
30d
Cleared
Jun 02, 1994
CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676
Dental
28d
Cleared
May 27, 1994
CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676
Dental
22d
Cleared
Jun 17, 1993
100 LIGHT CURE UNIT
Dental
269d