# K052800: Provisional Inlay/Onlay Kit

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Mar 7, 2006 after 155 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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 K992097 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042820: Systemp.C&B Plus, Ivoclar Vivadent, Inc. (2004) Summary page 1.
- K020092: Temphase, Kerr Dental Materials Center (2002) Summary page 1.
- K934978: Fermit N Light-Curing Temporary Filling Material, Ivoclar North America, Inc. (1993) Summary page 1.
- K926418: CLIP, Voco GmbH (1993) Summary page 1.
- K931084: Tempit, Centrix, Inc. (1993) Summary page 1.
- K011748: First Fill R.C.S., Jeneric/Pentron, Inc. (2001) Summary page 1.
- K032289: Fit Checker II, GC America, Inc. (2003) Summary page 1.

## Indications for use
The provisional inlay and onlay materials are light-curing composites for: * temporary care of inlay and onlay preparations * temporary obturation of implant screw access canals * relining material for prefabricated crowns * temporary (light cured) cement * individualization of splints * forming aids for matrices * bite registration FitInspector is an addition-curing silicone for: * control of precision of fit, marginal adaption and marginal gaps of: - inlays / onlays; - crowns and bridges; - cast metal cores, crowns; - metal denture bases; and * provisional cement for inlays, onlays, crowns and bridges

Source page: https://510kreport.com/device/K052800
Methodology: https://510kreport.com/methodology