Impression Tray
FDA 510(k) K872210 · Dentsply Intl.
510(k) numberK872210
Submission
- Device name
- Impression Tray
- Applicant
- Dentsply Intl.
York, PA, US - Received
- June 9, 1987
- Decision date
- June 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K912820 | Polyester Resin Hand Molded TrayEBH · Traditional | E&D Dental Products, Inc. | 08/21/1991SE |
| 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 |
More from Espe GmbH (Us)
| 510(k) | Device | Decision |
|---|---|---|
| K140347 | Ankylos C/X Implant SystemDZE · Traditional | 08/20/2014SE |
| K130862 | Cavitron Prophy-Jet Air Polishing Prophylaxis SystemELC · Traditional | 07/23/2013SE |
| K123615 | Iris - High Strength Glass CeramicEIH · Traditional | 02/22/2013SE |
| K103244 | Qmix 2IN1 Endodontic Irrigating SolutionKJJ · Traditional | 02/14/2011SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | 10/30/2009SE |
| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | 12/19/2007SE |
Questions and answers
When was Impression Tray cleared by the FDA?
Impression Tray (K872210) received a 510(k) decision of Substantially Equivalent on June 22, 1987, 13 days after the submission was received.
What is the product code of K872210?
The FDA product code is EBH – Material, Impression Tray, Resin, a Class I (low risk) device regulated under 21 CFR 872.3670.