# K101546: Endoform Dental Template

- Pathway: 510(k) (Special)
- Applicant: Mesynthes, Ltd.
- Decided: Jun 23, 2010 after 20 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921895 (1992). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092096: Endoform Dermal Template, Mesynthes, Ltd. (2010) Summary page 1.

## Indications for use
EndoforMmM Dermal Template is supplied sterile and is intended for single use in the treatment of the following wounds: partial and hill-thickness wounds pressure ulcers venous ulcers diabetic ulcers chromic vascular ulcers tunneled/undermined wounds surgical wounds (donor sites/grafts, post-Mob's surgery, post-laser surgery, podiatric, wound dehiscence) trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) draining wounds

Source page: https://510kreport.com/device/K101546
Methodology: https://510kreport.com/methodology