ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE— 510(k) K062277
Substantially EquivalentAtlantis Components, Inc.
FDA 510(k) clearance K062277 for ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE, Substantially Equivalent on 2006-12-20. Applicant: Atlantis Components, Inc.. Device class: 2.
Clearance details
- Applicant
- Atlantis Components, Inc.
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, US
Recent devices under product code NHA
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 NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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.