ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW— 510(k) K981858
Substantially EquivalentAtlantis Components, Inc.
FDA 510(k) clearance K981858 for ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW, Substantially Equivalent on 1999-03-22. Applicant: Atlantis Components, Inc.. Device class: 2.
Clearance details
- Applicant
- Atlantis Components, 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
- Cambridge, MA, US
Recent devices under product code DZE
view allMore clearances from Atlantis Components, Inc.
view all- K103020 — ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
- K073540 — ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT
- K073258 — ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT
- K072483 — ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
- K071946 — ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS
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.