Brink Pre-Maxillary Implant
FDA 510(k) K921580 · Implantech Associates, Inc.
510(k) numberK921580
Submission
- Device name
- Brink Pre-Maxillary Implant
- Applicant
- Implantech Associates, Inc.
Washington, DC, US - Received
- April 2, 1992
- Decision date
- May 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FZE – Prosthesis, Nose, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3680
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code FZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241253 | Medicon Epiplating SystemFZE · Traditional | Cmf Medicon Surgical, Inc. | 12/12/2024SE |
| K161548 | Osseointegrated FixturesFZE · Traditional | Southern Implants (Pty), Ltd. | 12/01/2016SE |
| K090803 | Hanson Medical Facial ImplantsFZE · Traditional | Hanson Medical, Inc. | 06/30/2010SE |
| K090630 | Nobel Biocare Endosseous Implants (Maxillofacial Indication)FZE · Traditional | Nobel Biocare AB | 06/02/2009SE |
| K071018 | Monarch Nasal ImplantFZE · Traditional | Hanson Medical, Inc. | 05/25/2007SE |
| K041690 | Monarch Nasal ImplantFZE · Traditional | Hanson Medical, Inc. | 02/11/2005SE |
| K021418 | Aart Nasal ImplantFZE · Traditional | Aesthetic and Reconstructive Technologies, Inc. | 07/02/2002SE |
| K992242 | Pillar Nasal, Dorsal Columella and Nasal Dorsum ImplantsFZE · Traditional | Pillar Surgical, Inc. | 11/22/1999SE |
| K983755 | Nasal Dorsal SeriesFZE · Special | Surgical Technology Laboratories, Inc. | 11/20/1998SE |
| K982753 | Seare Biomedical Nasal ImplantsFZE · Traditional | Seare Biomedical Corp. | 09/30/1998SE |
More from Seare Biomedical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K200610 | Customized Contour ImplantFWP · Traditional | 12/23/2020SE |
| K191130 | Customized Contour ImplantFWP · Traditional | 08/23/2019SE |
| K172389 | ePTFE-Coated Auricular ImplantFZD · Traditional | 07/18/2018SE |
| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | 07/10/2014SE |
| K071470 | Implantech Eptfe Sheeting, Model Eptfe-XxxFTL · Traditional | 08/31/2007SE |
| K052505 | Calf Implant, Model EC17-XMIB · Traditional | 11/04/2005SE |
| K052504 | Gluteal Implant, Models RND 5-X, TRD 6-XMIB · Traditional | 11/04/2005SE |
| K013732 | GelzoneMDA · Traditional | 02/07/2002SE |
| K012419 | Conform Sheeting, Model IgelMDA · Traditional | 10/24/2001SE |
| K002886 | Implantech Composite Facial Implants (Malar, Chin, and Nasal)LZK · Traditional | 11/24/2000SE |
Questions and answers
When was Brink Pre-Maxillary Implant cleared by the FDA?
Brink Pre-Maxillary Implant (K921580) received a 510(k) decision of Substantially Equivalent on May 6, 1992, 34 days after the submission was received.
What is the product code of K921580?
The FDA product code is FZE – Prosthesis, Nose, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3680.