# K983041: Seare Biomedical Silicone Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Seare Biomedical Corp.
- Decided: Sep 30, 1998 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Silicone Elastomer Sheeting manufactured and marketed by Dow Corning: named in the summary without a submission number
- (no number) Silicone Elastomer Sheeting manufactured and marketed by Bentec Medical: named in the summary without a submission number

## Most influential descendants
- K071823: Perma Facial Implants (2007), 0 descendants of its own

## Indications for use
For short term application the indications for usc arc: nasal splinting; wound dressings; management of hypentrophic or kcloid scarring; to prevent soft rissu¢ fibrosis or bony ankylosis following surgical correction of trismus; temporary joint spacers; laboratory uses. For long-term application the indications for use are; nasal septal repair; orbital floor reconstruction; tympanic membrane rcpair: dialysis shunt anchoring: duramater repair; staged repair of omphalaccic: - for lengthening extra ocular muscles in select cascs of suabxsmus. as a protective sheathing 10 help Facilitate neural regeneration and tendon anastomnosis; as a protective sheathing to hclp facilitate osteogenesis; guided tissue regeneration between teeth and gingival margin, ot external ear canal for example; other uses deemed appropriate by the using surgeon. Warning: Net for permanent use in Temporo Mandibular Joint applicasions,

Source page: https://510kreport.com/device/K983041
Methodology: https://510kreport.com/methodology