Aart Nasal Implant
FDA 510(k) K021418 · Aesthetic and Reconstructive Technologies, Inc.
510(k) numberK021418
Submission
- Device name
- Aart Nasal Implant
- Applicant
- Aesthetic and Reconstructive Technologies, Inc.
Reno, NV, US - Received
- May 3, 2002
- Decision date
- July 2, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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 |
| K981833 | Silimed Nasal L Shaped ImplantFZE · Traditional | Silimed, LLC | 06/26/1998SE |
More from Silimed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K023678 | Dimisil Scar GelMDA · Traditional | 01/23/2003SE |
| K022306 | Aart Silicone TubingKGZ · Traditional | 10/10/2002SE |
| K022511 | Aart Calf ImplantMIB · Traditional | 08/26/2002SE |
| K022223 | Aart Silicone SheetingMIB · Traditional | 08/08/2002SE |
| K021839 | Aart Gluteal ImplantMIB · Traditional | 07/16/2002SE |
| K021820 | Aart Silicone Carving BlockMIB · Traditional | 07/16/2002SE |
| K021337 | Aart Pectoralis ImplantMIC · Traditional | 07/03/2002SE |
| K021419 | Aart Malar ImplantLZK · Traditional | 07/02/2002SE |
| K021417 | Aart Chin ImplantFWP · Traditional | 07/02/2002SE |
Questions and answers
When was Aart Nasal Implant cleared by the FDA?
Aart Nasal Implant (K021418) received a 510(k) decision of Substantially Equivalent on July 2, 2002, 60 days after the submission was received.
What is the product code of K021418?
The FDA product code is FZE – Prosthesis, Nose, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3680.