Product code EJP
- Device name
- Articulators
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3150
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K926190 | ALRAND INC. (DENTAL HAND INSTRUMENTS) | Alrand, Inc. | 1994-01-18 |
| K896131 | GNATHOMAT ARTICULATOR | Ivoclar North America, Inc. | 1989-12-04 |
| K892373 | DENTAL PLASTIC BITE FORK | Texapol Corp. | 1989-06-12 |
| K884418 | PREMIER DIE-TRAK ARTICULATOR | Premier Medical | 1988-11-14 |
| K872943 | DISPOSABLE ARTICULATOR | Dentsply Intl. | 1987-08-11 |
| K863009 | GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX | Sds Dental, Inc. | 1986-09-25 |
| K854702 | PLASTIC MOUNTING RINGS | Almore Intl., Inc. | 1986-03-06 |
| K833039 | HANDY IIM | Shofu Dental Corp. | 1983-10-04 |
| K811075 | BALANCE ARTICULATOR | Almore Intl., Inc. | 1981-05-13 |
| K810971 | THE GNATOMET | Bauer, Cheng & Associates, Inc. | 1981-05-05 |
| K801342 | DISPOSABLE ARTICULATOR | Williams Gold Refining Co., Inc. | 1980-07-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D040342160 | MA2340 W/STRAPS | WHIP-MIX CORPORATION | 2025-09-11 |
| 00348783005813 | W.O.W.™ | PREMIER DENTAL PRODUCTS COMPANY | 2024-06-06 |
| 00348783005820 | W.O.W.™ | PREMIER DENTAL PRODUCTS COMPANY | 2024-06-06 |
| 00348783005837 | W.O.W.™ | PREMIER DENTAL PRODUCTS COMPANY | 2024-06-06 |
| 00348783005844 | W.O.W.™ | PREMIER DENTAL PRODUCTS COMPANY | 2024-06-06 |
| 00348783005851 | W.O.W.™ 2 | PREMIER DENTAL PRODUCTS COMPANY | 2024-06-06 |
| D040200114080 | Denar Mark 330 Articulator | WHIP-MIX CORPORATION | 2024-02-27 |
| D040200113780 | Denar Mark 320 Articulator | WHIP-MIX CORPORATION | 2024-02-27 |
| D040200113770 | Denar Mark 310 Articulator | WHIP-MIX CORPORATION | 2024-02-27 |
| 08800075601490 | OSUNG MND | OSUNG MND Co., Ltd. | 2024-02-22 |
| 08964003163570 | Doctor Nice | B. Ali Impex | 2024-01-29 |
| 08964003163587 | ECCO | B. Ali Impex | 2024-01-29 |
| E1997592331 | Articulator | Candulor AG | 2023-10-18 |
| 00816063020677 | iTero Articulator Kit | Align Technology, Inc. | 2021-06-04 |
| E23550700 | HANDY IIM | SHOFU DENTAL CORPORATION | 2021-02-03 |
| E23550760 | HANDY IIM | SHOFU DENTAL CORPORATION | 2021-02-03 |
| E23550750 | HANDY IIM | SHOFU DENTAL CORPORATION | 2021-02-03 |
| E23550740 | HANDY IIM | SHOFU DENTAL CORPORATION | 2021-02-03 |
| E23550730 | HANDY IIM | SHOFU DENTAL CORPORATION | 2021-02-03 |
| E23550710 | HANDY IIM | SHOFU DENTAL CORPORATION | 2021-02-03 |
| D0400033020001 | Hanau 96 H2 Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| D0400098560001 | Hanau-Mate Non-Adjustable Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| D0400108850001 | Hanau Wide-Vue Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| D0400141020001 | Hanau modular Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| D0400141160001 | Hanau modular Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| D0400143000001 | Hanau modular Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| D0400143090001 | Hanau modular Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| D0400145030001 | Hanau modular Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| D040022461 | 4640 Q Articulator | WHIP-MIX CORPORATION | 2020-09-22 |
| DIVO576821BN1 | Stratos 300 Grundausstattung | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2020-08-26 |