Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-195: ISO 14801 Second edition 2007-11-15, Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. (Dental/ENT)
Date of Standard: 2007. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
|
|
| Devices Affected: |
| Endosseous dental implant, Endosseous dental implant abutments |
|
| Processes Affected: |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard and any annexes. Data from the test methods is needed to support a declaration of conformity to this standard. Additional testing may be necessary for some products. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3630 |
Abutment, Implant, Dental, Endosseous |
Class 2 |
NHA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3640 |
Implant, Endosseous, Root-Form |
Class 2 |
DZE |
| |
|
| Relevant Guidance: |
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - May 12, 2004.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072424.htm |
|
| FDA Technical Contact: |
| Andrew Steen |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2604 |
| Silver Spring MD 20993 |
| 301/796-6284 |
| Email: andrew.steen@fda.hhs.gov |
|
|
