DeviceClearance

Product code DZE— Dental

S.I.N. Dental Implant System

Classification name
Implant, Endosseous, Root-Form
Device class
Class 2
Regulation
21 CFR 872.3640
Advisory panel
Dental
Total cleared
1,548
First cleared
Most recent

Market context for product code DZE

FDA has cleared 1,548 devices under product code DZE between 1976 and 2026, filed by 449 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code DZE

Adverse 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 →

Recent clearances under product code DZE

1–100 of 1,548

Data sourced from openFDA. This site is unofficial and independent of the FDA.