# K071235: Zimmer One Piece Implant, 3.0MM Angled, Models ZOP30A10, ZOP30A11 and ZOP30A13

- Pathway: 510(k) (Special)
- Applicant: Zimmer Dental, Inc.
- Decided: May 30, 2007 after 27 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052997 (2006). 1 ancestor in all.
47 later devices descend from it; 4 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052997: Zimmer Dental One-Piece Implant, Zimmer Dental, Inc. (2006) Summary page 2.
- (no number) Zimmer® Screw Vent® Mini™ 3.3mm + Zimmer® Contour Hex-Lock™ Abutment, 3.5mm: named in the summary without a submission number

## Most influential descendants
- K080594: MS System (Narrow Ridge) (2008), 42 descendants of its own
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K211090: ZENEX Implant System (2022), 8 descendants of its own
- K203360: EK Implants and Abutments System (2022), 7 descendants of its own
- K083067: MS System (2009), 7 descendants of its own

## Recalls of this device
- Jul 10, 2017 · Class II · Z-3210-2017: Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supp

## Indications for use
The 3.0mm One-Piece Implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The 3.0mm One-Piece implant must be splinted if two or more are used adjacent to each other. The 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Source page: https://510kreport.com/device/K071235
Methodology: https://510kreport.com/methodology