680/1 to 785/2 Various Types & Sizes of Root Eleva
FDA 510(k) K851713 · Artiberia
510(k) numberK851713
Submission
- Device name
- 680/1 to 785/2 Various Types & Sizes of Root Eleva
- Applicant
- Artiberia
San Antonio, TX, US - Received
- April 25, 1985
- Decision date
- June 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EMJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K870589 | Elevator, Root, Single-EndedEMJ · Traditional | Military Engineering, Inc. | 04/03/1987SE |
| K851717 | 880/1 to 890/4 Various Types of Perioteal ElevatorEMJ · Traditional | Artiberia | 06/14/1985SE |
| K850906 | Tactile Plus Dental ElevatorsEMJ · Traditional | Ipco Corp. | 04/12/1985SE |
| K821788 | Beach Deriosteal Elevator, #2 StraightEMJ · Traditional | Pacific Dental Corp. | 07/06/1982SE |
| K771747 | Periosteal ElevatorEMJ · Traditional | Depuy, Inc. | 09/28/1977SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851745 | 1-100 Universal Set Otoscope & Larynx Exploraton BERA · Traditional | 08/29/1985SE |
| K851786 | 27-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional | 07/09/1985SE |
| K851730 | 2710 to 2935 Various Pliers for Orthodontics/ProstEJY · Traditional | 07/02/1985SE |
| K851729 | 2620/1 to 2635/2 Various Dental Crown ScissorsEIR · Traditional | 07/02/1985SE |
| K851727 | 2020-1/2 to 2220 Various Dental Wax & Modelling CaEIK · Traditional | 07/02/1985SE |
| K851726 | 1760/1 to 2010/34 Various Dental Filling InstrumenEIY · Traditional | 07/02/1985SE |
| K851724 | 1410/1 to 1435/13 Various Probes & ExplorersEKB · Traditional | 07/02/1985SE |
| K851723 | 1300/10 to 1305/89-92 Various Cutting InstrumentsEKD · Traditional | 07/02/1985SE |
| K851722 | 1285/5 to 1295 Various Types of Dental ExcavatorsEKC · Traditional | 07/02/1985SE |
| K851721 | 1200/1 to 1240/15 Various Types of Dental ScalersEMN · Traditional | 07/02/1985SE |
Questions and answers
When was 680/1 to 785/2 Various Types & Sizes of Root Eleva cleared by the FDA?
680/1 to 785/2 Various Types & Sizes of Root Eleva (K851713) received a 510(k) decision of Substantially Equivalent on June 11, 1985, 47 days after the submission was received.
What is the product code of K851713?
The FDA product code is EMJ – Elevator, Surgical, Dental, a Class I (low risk) device regulated under 21 CFR 872.4565.