CU-100RLC Light Cure Unit, Document NO.A715676
FDA 510(k) K952423 · Rolence Enterprise Co. , Ltd.
510(k) numberK952423
Submission
- Device name
- CU-100RLC Light Cure Unit, Document NO.A715676
- Applicant
- Rolence Enterprise Co. , Ltd.
Chungli, Taiwan, TW - Received
- May 23, 1995
- Decision date
- June 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K980792 | CU-100A Light Cure UnitEBF · Traditional | 05/15/1998SE |
| K960364 | CU-200 Light Cure UnitEBZ · Traditional | 04/15/1996SE |
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Questions and answers
When was CU-100RLC Light Cure Unit, Document NO.A715676 cleared by the FDA?
CU-100RLC Light Cure Unit, Document NO.A715676 (K952423) received a 510(k) decision of Substantially Equivalent on June 22, 1995, 30 days after the submission was received.
What is the product code of K952423?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.