# K063780: Ace Bond SE

- Pathway: 510(k) (Special)
- Applicant: Bisco, Inc.
- Decided: Jan 19, 2007 after 29 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
No predicates in its family tree.
10 later devices descend from it; 2 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K050647: All-in-One, Bisco, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K112118: Dreambond (2011), 8 descendants of its own
- K161051: All-Bond Universal w/BAC (not finalized) (2016), 6 descendants of its own
- K230465: Hi-Bond Universal (2023), 2 descendants of its own
- K240743: Peak Universal Bond (2024), 1 descendant of its own
- K213401: DIAPLUS Universal (2022), 1 descendant of its own

## Indications for use
As a Universal Self-Etching Adhesive System, ACE BOND SE, as the name implies, is the only product one needs to etch, prime, and bond to a tooth structure and dental substrates. ACE BOND SE is used for: 1.Direct restorations (composite, amalgam) 2. All indirect restorations (composite, metal, porcelain) 3. Desensitization of crown preparations prior to impression making/provisionatization 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/K063780
Methodology: https://510kreport.com/methodology