ENDOSSEOUS DENTAL IMPLANT SYSTEM— 510(k) K071161
Substantially EquivalentSouthern Implants, Inc.
FDA 510(k) clearance K071161 for ENDOSSEOUS DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2007-11-16. Applicant: Southern Implants, Inc.. Device class: 2.
Clearance details
- Applicant
- Southern Implants, Inc.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fairfax, VA, US
Recent devices under product code DZE
view allMore clearances from Southern Implants, Inc.
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K071161
K-number listed on FDA's recall record- Z-0718-2018 — Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
- Z-1265-2015 — MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K071161.
Data sourced from openFDA. This site is unofficial and independent of the FDA.