Articulators
FDA product code EJP · Class I (low risk) · 21 CFR 872.3150 · Dental
11510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 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 |
| K810971 | The GnatometEJP · Traditional | Bauer, Cheng & Associates, Inc. | 05/05/1981SE |
| K801342 | Disposable ArticulatorEJP · Traditional | Williams Gold Refining Co., Inc. | 07/08/1980SE |