Alrand Inc. (Dental Hand Instruments)
FDA 510(k) K926190 · Alrand, Inc.
510(k) numberK926190
Submission
- Device name
- Alrand Inc. (Dental Hand Instruments)
- Applicant
- Alrand, Inc.
Boca Raton, FL, US - Received
- December 9, 1992
- Decision date
- January 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Alrand Inc. (Dental Hand Instruments) cleared by the FDA?
Alrand Inc. (Dental Hand Instruments) (K926190) received a 510(k) decision of Substantially Equivalent on January 18, 1994, 405 days after the submission was received.
What is the product code of K926190?
The FDA product code is EJP – Articulators, a Class I (low risk) device regulated under 21 CFR 872.3150.