# K102347: Grandtec

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Oct 29, 2010 after 71 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
GrandTEC is intended for the following applications: - Stabilisation of teeth: After orthodontic treatment After periodontal treatment - For support in treating trauma: For immobilising and splinting avulsed and loosened teeth Fragment anchoring after fracture - For the reinforcement/fabrication of provisional bridges made from composite and provisional C & B material - For temporary treatment after extraction and replacement of a missing tooth with the use of a plastic tooth - For the temporary or semi-permanent treatment of a tooth space with the use of an extracted natural tooth - For temporary treatment after placing an implant during the osseointegration of the implant

Source page: https://510kreport.com/device/K102347
Methodology: https://510kreport.com/methodology