ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT— 510(k) K110640
Substantially EquivalentAstra Tech, Inc.
FDA 510(k) clearance K110640 for ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT, Substantially Equivalent on 2011-06-10. Applicant: Astra Tech, Inc.. Device class: 2.
Clearance details
- Applicant
- Astra Tech, 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 Astra Tech, Inc.
view all- K122078 — LOFRIC PRIMO, LOFRIC HYDRO-KIT
- K120338 — ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA
- K113003 — ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
- K112138 — ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT
- K110356 — ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
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.