# K180924: Reflect Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ids - Integrated Dental Systems
- Decided: Mar 29, 2019 after 354 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: 12 generations back to K894595 (1990). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.

## Indications for use
Reflect™ Dental Implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Reflect™ Dental Implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Reflect™ Implant System prosthetic components are compatible with the following implant systems. Implant System Compatibility Implant Body Diameter (mm) Platform Diameter (mm) OsseoSpeed™ 3.5 3.5/4.0 4.0 3.5/4.0 5.0 4.5/5.0 3i Certain® 3.25 3.4 4.0 4.1 5.0 5.0 NobelActive® 3.5 NP 4.3 RP 5.0 RP NobelReplace Conical 3.5 NP 4.3 RP 5.0 RP Tapered Screw-Vent® 3.7 3.5 4.1 3.5 4.7 4.5

Source page: https://510kreport.com/device/K180924
Methodology: https://510kreport.com/methodology