# K980442: Crystal and Crystal-Seal Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Crystal Medical Technology
- Decided: Mar 16, 1998 after 40 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- 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 K820013 (1982). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954432: Crystal & Crystal-Plus Implants System, Crystal Medical Technology (1996) Summary page 1.
- K924112: Hydroxylapatite Coated Saber Tech Series I & Series II, Saber Technology, Inc. (1994) Summary page 1.
- K820013: Titanium Implant Devices, Bofors Nobelpharma, Inc. (1982) Summary page 2.
- K861426: Screw-Vent (TM) Implant/Endosseous Screw Implant, Core-Vent Corp. (1986) Summary page 2.
- K892124: Impla-Med Implant System, Impla-Med (1989) Summary page 2.
- K921854: Impla-Med Hex Screw Implants, 18 and 20 MM, Impla-Med (1992) Summary page 2.
- K852802: Denar Dental Implant, Denar Corp. (1985) Summary page 2.
- K884845: Steri-Oss, Denar Corp. (1989) Summary page 2.
- K891346: Artech Type SS Submerged Screw Implant, Artech Corp. (1989) Summary page 2.
- K895267: Artech Type SS-HA Submerged Screw Implant, Artech Corp. (1990) Summary page 2.
- K915375: Odontit Osseointegrated Implants System, Odontit Systeme (1992) Summary page 2.

## Most influential descendants
- K034067: Zti Implants System, DRM Implants (2004), 0 descendants of its own

## Indications for use
This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Source page: https://510kreport.com/device/K980442
Methodology: https://510kreport.com/methodology