# K022223: Aart Silicone Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic and Reconstructive Technologies, Inc.
- Decided: Aug 8, 2002 after 30 days
- Product code: MIB (Elastomer, Silicone Block)
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Seare Biomedical Silicone Sheeting: named in the summary without a submission number

## Most influential descendants
- K033796: Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS (2004), 1 descendant of its own
- K260266: Tympendi™ (810) (2026), 0 descendants of its own
- K071823: Perma Facial Implants (2007), 0 descendants of its own

## Indications for use
The AART Silicone Sheeting has a variety of intmded uses. The Silicone sh- is intended for short term and long term applications. Short tenn indications for use: Nasal splmtmg Wound dressing Management of keloid or hypertrophic scarring TemporaryuseinTMJdiseas? Tempomyjoint shims Laboratory-uses Long term indications for use: Nasal septal repair Orbital floor reconstnrclion Tympanic membrane repair Dialysis shrmt d o l j n g Duramekr repair Staged repair of omphalocoel hgthenkgofext~aocularmuscles As a protective sheathing to help facilitateneural regmerztion and tendon anastomosis As a protective sheatlungto help facilitate osteogenesis Other uses deemed appropriate by the using surgeon Caution: The American Academy of Oral Maxillofacial Surgeons recomniends against the use of silicone products for permanent treatmeat of Temporo Mapctibular Joint Disease.

Source page: https://510kreport.com/device/K022223
Methodology: https://510kreport.com/methodology