Alastigard
FDA 510(k) K890529 · Unitek Corp.
510(k) numberK890529
Submission
- Device name
- Alastigard
- Applicant
- Unitek Corp.
Monrovia, CA, US - Received
- February 2, 1989
- Decision date
- March 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K994357 | Bitem Lock, Models SW006, SW012EJF · Traditional | Thermoelastic Technologies, Inc. | 03/14/2000SE |
| K932825 | Microarch Gold BracketEJF · Traditional | Gac Intl., Inc. | 05/09/1994SE |
| K933501 | AlastikEJF · Traditional | Unitek Corp. | 04/28/1994SE |
| K923372 | Memory WireEJF · Traditional | Althan, Inc. | 04/22/1994SE |
| K933080 | Orthotech Dura-Gold BarcketsEJF · Traditional | Orthotech | 03/23/1994SE |
| K935139 | Fascination Ceramic BracketEJF · Traditional | Dentauraum, Inc. | 02/04/1994SE |
| K936244 | Regency BracketEJF · Traditional | Mid-American Dental Specialties, Inc. | 02/02/1994SE |
| K934881 | ReflectionsEJF · Traditional | Cdb Corp. | 02/01/1994SE |
| K935122 | Dentaurum Metal BracketsEJF · Traditional | Dentauraum, Inc. | 01/31/1994SE |
| K926427 | Lariat Palate ExpanderEJF · Traditional | Easy Access Orthodontics, Inc. | 01/26/1994SE |
More from Easy Access Orthodontics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K944286 | Metal-Lined Transcend Ceramic BracketDYW · Traditional | 11/29/1994SE |
| K933501 | AlastikEJF · Traditional | 04/28/1994SE |
| K940165 | AlastikECI · Traditional | 03/07/1994SE |
| K923999 | Alastik NSECI · Traditional | 06/24/1993SE |
| K924645 | Transcend Series 6000 Debonding InstrumentsJEX · Traditional | 11/25/1992SE |
| K924295 | Debracketing InstrumentJEX · Traditional | 11/23/1992SE |
| K923432 | German Mini DynalockEJF · Traditional | 10/30/1992SE |
| K911271 | Adhesive Precoated BracketsDYH · Traditional | 05/29/1991SE |
| K910288 | Nonstaining AlastiksEJF · Traditional | 03/29/1991SE |
| K880392 | Ortholux Visible Light Curing UnitEBZ · Traditional | 04/07/1988SE |
Questions and answers
When was Alastigard cleared by the FDA?
Alastigard (K890529) received a 510(k) decision of Substantially Equivalent on March 9, 1989, 35 days after the submission was received.
What is the product code of K890529?
The FDA product code is EJF – Bracket, Metal, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.5410.