PDQ AND PDQ-TI ABUTMENT— 510(k) K990367
Substantially EquivalentVident
FDA 510(k) clearance K990367 for PDQ AND PDQ-TI ABUTMENT, Substantially Equivalent on 1999-04-21. Applicant: Vident. Device class: 2.
Clearance details
- Applicant
- Vident
- 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
- Brea, CA, US
Recent devices under product code DZE
view allMore clearances from Vident
view all- K063768 — TITANIUM SCALLOPED ABUTMENT
- K060441 — VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98
- K052710 — VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,
- K052130 — VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
- K050362 — VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.