R2+
FDA 510(k) K934758 · Jeneric/Pentron, Inc.
510(k) numberK934758
Submission
- Device name
- R2+
- Applicant
- Jeneric/Pentron, Inc.
Wallingford, CT, US - Received
- October 4, 1993
- Decision date
- February 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K040179 | ContinumEJH · Traditional | Aalba Dent, Inc. | 03/03/2004SE |
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| K032136 | Wirobond CEJH · Traditional | Bego U.S.A. | 09/04/2003SE |
| K031627 | Nano-TicrownEJH · Traditional | Nano-Write Corp. | 06/11/2003SE |
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| K030161 | SuperbondEJH · Traditional | American Dent-All, Inc. | 03/17/2003SE |
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| K012231 | Avante Micro Crystal SystemEIH · Traditional | 08/23/2001SE |
| K011748 | First Fill R.C.S.KIF · Traditional | 08/03/2001SE |
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| 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 |
Questions and answers
When was R2+ cleared by the FDA?
R2+ (K934758) received a 510(k) decision of Substantially Equivalent on February 18, 1994, 137 days after the submission was received.
What is the product code of K934758?
The FDA product code is EJH – Alloy, Metal, Base, a Class II (moderate risk) device regulated under 21 CFR 872.3710.