# K974089: Alloy Primer

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray America, Inc.
- Decided: Dec 17, 1997 after 49 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 K871636 (1987). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942017: V-Primer, Parkell, Inc. (1994). Our OCR of the scanned summary read K942917, FDA’s number for Ultrapro Workstation (Ramsoft, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “V-PRIMER”.
- K970848: Siloc System, Heraeus Kulzer, Inc. (1997) Summary page 3.
- K871636: Clearfil Porcelain Bond, Kuraray Co. (1987) Summary page 3.
- (no number) ACRYLIC SOLDER by PARKELL PRODUCT, INC.: named in the summary without a submission number

## Most influential descendants
- K012436: Modification to Alloy Primer (2001), 2 descendants of its own
- K171226: Tokuyama Universal Bond (2017), 1 descendant of its own
- K251587: VITA VMLC Primer (2026), 0 descendants of its own
- K203760: Tokuyama Universal Bond II (2021), 0 descendants of its own
- K052189: Reveneer Ceramic Repair System (2005), 0 descendants of its own

## Indications for use
This device is used for the following indications. All of these intended use are same to those of predicate devices. 1) Adhesion of metal posts, metal inlays, onlays, crown and bridges. 2) Repair of fractures resin-based facing crowns and porcelain-fused metal crowns 3) Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures

Source page: https://510kreport.com/device/K974089
Methodology: https://510kreport.com/methodology