# K063170: Tender Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Micerium S.P.A.
- Decided: Jan 12, 2007 after 86 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
Longest line of descent: 3 generations back to K003333 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011788: Everstick, Stick Tech, Ltd. (2001)
- K030072: Everstick Perio, Stick Tech, Ltd. (2003) Summary page 2.
- K021126: Everstick Ortho, Stick Tech, Ltd. (2002) Summary page 2.
- K003333: STICK, Stick Tech, Ltd. (2001) Summary page 2.
- K913040: Ribbond (TM), Ribbond, Inc. (1991) Summary page 2.

## Indications for use
Tender fiber is a semi-manufactured product made of fibers used to reinforce composite and acrylic prosthodontic appliances and to repair or reinforce denture and orthodontic appliances. It can be used as well to immobilize teeth for periodontic or orthodontic treatments. These products are for use only by trained and experienced dentists and dental technicians and have become well-known in this area of dentistry, therefore they do not require prescription (Per 21 CFR 801 Subpart D)

Source page: https://510kreport.com/device/K063170
Methodology: https://510kreport.com/methodology