Polyester Resin Hand Molded Tray
FDA 510(k) K912820 · E&D Dental Products, Inc.
510(k) numberK912820
Submission
- Device name
- Polyester Resin Hand Molded Tray
- Applicant
- E&D Dental Products, Inc.
Westfield, NJ, US - Received
- June 25, 1991
- Decision date
- August 21, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K933745 | Permagen Universal Bonding ResinEBH · Traditional | Bio-Systems Research | 01/26/1994SE |
| K930487 | Palatray LC MintEBH · Traditional | Heraeus Kulzer, Inc. | 06/18/1993SE |
| K923979 | LC Tray MaterialEBH · Traditional | Dentsply Intl. | 11/17/1992SE |
| K923549 | Paladisc LCEBH · Traditional | Heraeus Kulzer, Inc. | 09/29/1992SE |
| K905058 | Palavit LEBH · Traditional | Kulzer, Inc. | 06/06/1991SE |
| K902350 | Palatray LC Resin Impression Tray MaterialEBH · Traditional | Kulzer, Inc. | 07/26/1990SE |
| K901782 | Convertray Custom Impression Tray Material SystemEBH · Traditional | Productivity Training Corp. | 06/29/1990SE |
| K890712 | Advantage Dental Cust Dent Impress/Baseplate TraysEBH · Traditional | Advantage Dental Products, Inc. | 04/25/1989SE |
| K881838 | Modified Permagum AdhesiveEBH · Traditional | Espe GmbH (Us) | 07/27/1988SE |
| K875257 | Impregum F AdhesiveEBH · Traditional | Espe GmbH (Us) | 03/09/1988SE |
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Questions and answers
When was Polyester Resin Hand Molded Tray cleared by the FDA?
Polyester Resin Hand Molded Tray (K912820) received a 510(k) decision of Substantially Equivalent on August 21, 1991, 57 days after the submission was received.
What is the product code of K912820?
The FDA product code is EBH – Material, Impression Tray, Resin, a Class I (low risk) device regulated under 21 CFR 872.3670.