# K050647: All-in-One

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Apr 20, 2005 after 37 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910860 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001494: Modification to Prompt L-Pop, Espe Dental AG (2000)
- K910860: All-Bond 2, Bisco, Inc. (1991) Summary page 1.

## Indications for use
As a Universal Self-Etching Adhesive System, ALL-IN-ONE Adhesive, as the name implies, is the only product one needs to etch, prime, and bond to a tooth structure and dental substrates. ALL-IN-ONE is used for: 1. Direct restorations (composite, amalgam) 2. All indirect restorations (composite, metal, porcelain) 3. Desensitization of crown preparations prior to impression making/provisionalization 4. Composite core build-ups 5. Composite to metal/set amalgam (direct veneering) 6. Root desensitization 7. New amalgam to existing amalgam 8. Repairs (composite-to-composite, composite-to-porcelain)

Source page: https://510kreport.com/device/K050647
Methodology: https://510kreport.com/methodology