External Hex Implants— 510(k) K163634
Substantially EquivalentSouthern Implants (Pty), Ltd.
FDA 510(k) clearance K163634 for External Hex Implants, Substantially Equivalent on 2017-11-06. Applicant: Southern Implants (Pty), Ltd.. Device class: 2.
Clearance details
- Applicant
- Southern Implants (Pty), Ltd.
- 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
- Guateng, ZA
Recent devices under product code DZE
view allMore clearances from Southern Implants (Pty), Ltd.
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 K163634
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163634.
Data sourced from openFDA. This site is unofficial and independent of the FDA.