# K052997: Zimmer Dental One-Piece Implant

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Dental, Inc.
- Decided: Jan 23, 2006 after 90 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
No predicates in its family tree.
245 later devices descend from it; 10 cite it directly.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zimmer Dental Inc., Screw-Vent® MTX™ Selective Surface Implant (Cat. No. SVMB13) / Zimmer Dental Hex-Lock™ Abutment (Cat. No. HLA3/3): named in the summary without a submission number
- (no number) Nobel Biocare Inc., NobelDirect™ 3.0 (Cat. No. 31456): named in the summary without a submission number

## Most influential descendants
- K081653: Mdi Mii One-Piece Implant, 2.9MM (2008), 141 descendants of its own
- K123022: Neodent Implant System (2013), 127 descendants of its own
- K133510: Neodent Implant System (2014), 123 descendants of its own
- K061410: Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant System,AV;Zimmer One-Piece Implant (2006), 122 descendants of its own
- K133592: Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua and Drive Smart Acqua, Titamax CM (2014), 109 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
Zimmer® One-Piece 3.7mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in functional occlusion. Zimmer® One-Piece 3.0mm 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 Zimmer® One-Piece 3.0mm implant must be splinted if two or more are used adjacent to each other. The Zimmer® One-Piece 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Source page: https://510kreport.com/device/K052997
Methodology: https://510kreport.com/methodology