The Gnatomet
FDA 510(k) K810971 · Bauer, Cheng & Associates, Inc.
510(k) numberK810971
Submission
- Device name
- The Gnatomet
- Applicant
- Bauer, Cheng & Associates, Inc.
Mchenry, IL, US - Received
- April 9, 1981
- Decision date
- May 5, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926190 | Alrand Inc. (Dental Hand Instruments)EJP · Traditional | Alrand, Inc. | 01/18/1994SE |
| K896131 | Gnathomat ArticulatorEJP · Traditional | Ivoclar North America, Inc. | 12/04/1989SE |
| K892373 | Dental Plastic Bite ForkEJP · Traditional | Texapol Corp. | 06/12/1989SE |
| K884418 | Premier Die-Trak ArticulatorEJP · Traditional | Premier Medical | 11/14/1988SE |
| K872943 | Disposable ArticulatorEJP · Traditional | Dentsply Intl. | 08/11/1987SE |
| K863009 | Gnatus Articulator 4.300/4.300GP 8.600 & OrtoflexEJP · Traditional | Sds Dental, Inc. | 09/25/1986SE |
| K854702 | Plastic Mounting RingsEJP · Traditional | Almore Intl., Inc. | 03/06/1986SE |
| K833039 | Handy IimEJP · Traditional | Shofu Dental Corp. | 10/04/1983SE |
| K811075 | Balance ArticulatorEJP · Traditional | Almore Intl., Inc. | 05/13/1981SE |
| K801342 | Disposable ArticulatorEJP · Traditional | Williams Gold Refining Co., Inc. | 07/08/1980SE |
More from Williams Gold Refining Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K840084 | Coltene Brilliant LuxEBF · Traditional | 03/30/1984SE |
| K840085 | Coltene BrilliantEBF · Traditional | 03/16/1984SE |
| K823100 | RX 91EJS · Traditional | 11/10/1982SE |
| K823099 | RX MidacastEJT · Traditional | 11/10/1982SE |
| K823098 | Rex-CapsEJJ · Traditional | 11/10/1982SE |
| K823097 | NaturelleEJS · Traditional | 11/10/1982SE |
| K823084 | ChallengerEJS · Traditional | 11/10/1982SE |
| K810972 | The Gnathometer-MKZO · Traditional | 05/05/1981SE |
| K810970 | Isosit TeethELM · Traditional | 05/05/1981SE |
| K810969 | Isosit C & B MaterialEBF · Traditional | 05/05/1981SE |
Questions and answers
When was The Gnatomet cleared by the FDA?
The Gnatomet (K810971) received a 510(k) decision of Substantially Equivalent on May 5, 1981, 26 days after the submission was received.
What is the product code of K810971?
The FDA product code is EJP – Articulators, a Class I (low risk) device regulated under 21 CFR 872.3150.