# K974727: Jet Acrylic Liquid-Monomer, Ortho Jet Powder-Polymer, Plasticized Methacrylate Homopolymer, Methacrylate Copolymer, Metr

- Pathway: 510(k) (Traditional)
- Applicant: J.B.C and Co.
- Decided: Feb 24, 1998 after 68 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- 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 no predicate by number.

## Indications for use
Methyl methacrylate monomer and polymer is used to form a hard acrylic plastic during the fabrication of dental appliances. 1. Orthodontic and Dental laboratories: a. to be used by qualified dental/orthodontic technicians trained in the fabrication of orthodontic and pedodontic, fixed and removable appliances. b. trained in the proper use, precautions and hazards of dental resins c. the actual fabrication of these dental devices must first be preceded by an authorized prescription for such a device, by a licensed dental practitioner. 2. Dental Offices/Clinics a. to be used by qualified dentists/dental assistants trained in the fabrication of orthodontic, pedodontic fixed and removable appliances. b. to be used by qualified dentists/dental assistants trained in the proper use, precautions and hazards of dental resins c. to be used under the direct supervision of a licensed dental practitioner

Source page: https://510kreport.com/device/K974727
Methodology: https://510kreport.com/methodology