Rolence Ent. Inc.
CHUNGLI Taoyuan, TW
ROLENCE ENT. INC. appears in FDA device records in CHUNGLI Taoyuan, TW. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Rolence Ent. Inc. between 2002 and 2009. The busiest year on record is 2002, with 4. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 4 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093084 | ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP | EFB | Substantially Equivalent | |
| K023545 | ULTRA-LITE 200E LIGHT CURE UNIT | EBZ | Substantially Equivalent | |
| K020884 | EXCELLITE LIGHT CURE UNIT | EBZ | Substantially Equivalent | |
| K020877 | EXCELLITE TURBO LIGHT CURE UNIT | EBZ | Substantially Equivalent | |
| K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | EBZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8044167 | 3002772487 | ROLENCE ENT. INC. | 18-3 LANE 231 PU CHUNG RD., CHUNGLI Taoyuan 32083 TW | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EBZActivator, Ultraviolet, For Polymerization
- EJLBur, Dental
- EHKCup, Prophylaxis
- EFBHandpiece, Air-Powered, Dental
- EEGHeat Source For Bleaching Teeth
- DYNMouthpiece, Saliva Ejector
- ELCScaler, Ultrasonic
- MUHSystem, X-Ray, Extraoral Source, Digital
- EIAUnit, Operative Dental
- ECBUnit, Syringe, Air And/Or Water
- EHDUnit, X-Ray, Extraoral With Timer
- EFCWarmer, Anesthetic Tube
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain