# K151169: OsteoReady ZircoSeal Abutments

- Pathway: 510(k) (Traditional)
- Applicant: Osteoready, LLC
- Decided: Oct 8, 2015 after 160 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K960026 (1996). 204 ancestors in all.
No later device cites it as a predicate yet.
0 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123386: Periotype X-Pert, Clinical House Europe GmbH (2013) Summary page 4.
- K112440: AB Dental Devices Implants and Accessories, A.B. Dental Devices, Ltd. (2012) Summary page 4.
- K051719: A.B. Dental Devices, A.B. Dental Devices, Ltd. (2006) Summary page 4.
- K130829: IQ Implants; IQ Implants; IQ Implants Abutments, Iq Implants, Ltd. (2013) Summary page 5.

## Indications for use
OsteoReady® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6;

Source page: https://510kreport.com/device/K151169
Methodology: https://510kreport.com/methodology