BOND-1 C & B
FDA 510(k) K013543 · Jeneric/Pentron, Inc.
510(k) numberK013543
Submission
- Device name
- BOND-1 C & B
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- October 17, 2001
- Decision date
- February 22, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K020499 | BOND-3 AdhesiveKLE · Traditional | 04/22/2002SE |
| K013542 | Dentin Conditioning and Adhesive System (BOND-1)KLE · Traditional | 02/14/2002SE |
| K012231 | Avante Micro Crystal SystemEIH · Traditional | 08/23/2001SE |
| K011748 | First Fill R.C.S.KIF · Traditional | 08/03/2001SE |
| K010957 | Quell DesensitizerLBH · Traditional | 06/25/2001SE |
| K011331 | JP Cast 40EJT · Traditional | 06/22/2001SE |
| K011330 | JP Cast 50EJT · Traditional | 06/22/2001SE |
| K011362 | Gold Core 73 LSEJT · Traditional | 05/29/2001SE |
| K010044 | CosmicEJT · Traditional | 02/09/2001SE |
| K003683 | Avante CurelightEBZ · Traditional | 01/11/2001SE |
Questions and answers
When was BOND-1 C & B cleared by the FDA?
BOND-1 C & B (K013543) received a 510(k) decision of Substantially Equivalent on February 22, 2002, 128 days after the submission was received.
What is the product code of K013543?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.