Unitek Convertible Cap Remover Tool
FDA 510(k) K843742 · Unitek Corp.
510(k) numberK843742
Submission
- Device name
- Unitek Convertible Cap Remover Tool
- Applicant
- Unitek Corp.
Monrovia, CA, US - Received
- September 25, 1984
- Decision date
- November 9, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955242 | Titanium Bird Beak PlierJEX · Traditional | Sybron Dental Specialties, Inc. | 12/01/1995SE |
| K935141 | Dentaurum PliersJEX · Traditional | Dentauraum, Inc. | 01/31/1994SE |
| K924645 | Transcend Series 6000 Debonding InstrumentsJEX · Traditional | Unitek Corp. | 11/25/1992SE |
| K924295 | Debracketing InstrumentJEX · Traditional | Unitek Corp. | 11/23/1992SE |
| K854088 | Unitek Lift-Off Debracketing InstrumentJEX · Traditional | Unitex Corp. | 11/26/1985SE |
| K760984 | Orthodontic InstrumentsJEX · Traditional | Adp Intl., Inc. | 11/15/1976SE |
More from Adp Intl., 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 |
| K890529 | AlastigardEJF · Traditional | 03/09/1989SE |
Questions and answers
When was Unitek Convertible Cap Remover Tool cleared by the FDA?
Unitek Convertible Cap Remover Tool (K843742) received a 510(k) decision of Substantially Equivalent on November 9, 1984, 45 days after the submission was received.
What is the product code of K843742?
The FDA product code is JEX – Plier, Orthodontic, a Class I (low risk) device regulated under 21 CFR 872.4565.