# K073097: Tutodent Dental Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Tutogen Medical U.S., Inc.
- Decided: May 12, 2008 after 193 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 4 cite it directly.
0 of 11 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) TutoPatch membrane: named in the summary without a submission number
- (no number) Collagen Dental Membrane: named in the summary without a submission number
- (no number) Bio-Gide Resorbable Membrane: named in the summary without a submission number
- (no number) BioMend Extend: named in the summary without a submission number

## Most influential descendants
- K101453: Vitala Natural Resorbable Collagen Membrane (2011), 4 descendants of its own
- K141177: Vitala Porcine Derived Collagen Membrane (2015), 3 descendants of its own
- K090216: Collagen Dental Membrane IV (2009), 3 descendants of its own
- K173562: Straumann Jason Membrane (2018), 2 descendants of its own
- K100156: Collagen Dental Membrane V (2010), 1 descendant of its own

## Indications for use
This membrane is intended for use in oral surgical procedures as a resorbable material for augmentation around implants placed in immediate extraction sockets, augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Source page: https://510kreport.com/device/K073097
Methodology: https://510kreport.com/methodology