# K974458: Compolute Aplicap

- Pathway: 510(k) (Traditional)
- Applicant: Espe Dental-Medizin GmbH & Co.Kg.
- Decided: Feb 2, 1998 after 69 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900510 (1990). 3 ancestors in all.
70 later devices descend from it; 2 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913966: Sono (R) -Cem, Espe GmbH (Us) (1992) Summary page 1.
- K962440: Pertac II/Pertac II Aplitip, Espe GmbH & Co. Kg. (1996) Summary page 1.
- (no number) Panavia® 21: named in the summary without a submission number
- (no number) Variolink II: named in the summary without a submission number
- (no number) Scotchbond Resin Cement: named in the summary without a submission number
- (no number) Nexus dental cements: named in the summary without a submission number

## Most influential descendants
- K020256: Unicem (2002), 63 descendants of its own
- K043043: Hermes Bond 2 (2005), 37 descendants of its own
- K071131: UNO (2007), 35 descendants of its own
- K110302: Adhesive Exl-759 (2011), 34 descendants of its own
- K100756: MALTA (2010), 19 descendants of its own

## Indications for use
Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers

Source page: https://510kreport.com/device/K974458
Methodology: https://510kreport.com/methodology