Home / 510(k) Clearances / K021417

510(k) K021417

AART CHIN IMPLANT by Aesthetic and Reconstructive Technologies, Inc. — Product Code FWP

K021417 is an FDA 510(k) premarket notification submitted by Aesthetic and Reconstructive Technologies, Inc. for the device "AART CHIN IMPLANT". The FDA issued a decision of Substantially Equivalent on July 2, 2002. The device falls under product code FWP (Prosthesis, Chin, Internal), a Class II device regulated under 21 CFR 878.3550. Aesthetic and Reconstructive Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2002
Date Received
May 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Aesthetic and Reconstructive Technologies, Inc.

  • K023678 — DIMISIL SCAR GEL (January 23, 2003)
  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K022511 — AART CALF IMPLANT (August 26, 2002)
  • K022223 — AART SILICONE SHEETING (August 8, 2002)
  • K021820 — AART SILICONE CARVING BLOCK (July 16, 2002)
  • K021839 — AART GLUTEAL IMPLANT (July 16, 2002)
  • K021337 — AART PECTORALIS IMPLANT (July 3, 2002)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K021419 — AART MALAR IMPLANT (July 2, 2002)

Other clearances for product code FWP

  • K254233 — MEDPOR Customized Implant Kit (March 12, 2026)
  • K232593 — FITme Customized Silicone Implant (November 22, 2023)
  • K200610 — Customized Contour Implant (December 23, 2020)
  • K191130 — Customized Contour Implant (August 23, 2019)
  • K191916 — Stryker CMF MEDPOR Priority Customized Implant Kit (August 15, 2019)
  • K153508 — Stryker CMF MEDPOR Customized Implant (February 5, 2016)
  • K152463 — SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant (January 20, 2016)
  • K143173 — Stryker CMF MEDPOR Customized Implant (March 23, 2015)
  • K141027 — 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, S (July 10, 2014)
  • K121315 — STRYKER CMF MEDPOR CUSTOMIZED IMPLANT (November 1, 2012)

FDA data resources