# K970484: Accu-Prep

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Jul 1, 1997 after 141 days
- Product code: KOJ (Airbrush)
- Device class: 2
- Regulation: 21 CFR 872.6080
- 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 its predicate without a number.
- (no number) Microetcher: named in the summary without a submission number

## Indications for use
1. Maryland Bridges (resin bonded bridges): for preparation of cast metal framework of both non-precious (Ni-Cr) and noble (Au, Pt, Pd) alloys. 2. Cast restoration cementation: for preparation of intaglio surface of cast metal restorations to enhance micromechanical bonding especially of traditional cements (zinc phosphate). 3. Porcelain repair: for preparation of exposed metal (and porcelain) to repair failed porcelain fused to metal restoration intra-orally. 4. Porcelain etch substitute: for preparation of intaglio surface of porcelain restorations in place of etching with hydrofluoric acid in the mouth. 5. Composite surface preparation substitute: for preparation of intaglio surface of composite or polymeric restoration in place of surface active agents (i.e. methyl methacrylate). 6. Composite/polymeric restoration repair: for preparation of exposed failed restoration as in 5 above. 7. Repair of acrylic facings on cast restorations: for preparation of cast metal surface to enhance bond of self-cure acrylic facing to restoration. 8. Endodontic post preparation: for preparation of endo post to enhance micromechanical bond of post to prepared tooth. 9. Denture repairs: for preparation of denture base to facilitate repairs. 10. Orthodontic applications: for preparation of ortho brackets to enhance bonding to the bracket. For cement removal from brackets before re-bonding. For enhancement of adhesive to tooth structure.

Source page: https://510kreport.com/device/K970484
Methodology: https://510kreport.com/methodology