Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 4-121: ISO 7494-2 First edition 2003-03-01, Dentistry - Dental units - Part 2: Water and air supply. (Dental/ENT)
Date of Standard: 2003. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF DEVICE EVALUATION (ODE) | | |
|
| (2) | OFFICE OF COMPLIANCE (OC) | | |
|
|
| Devices Affected: |
| Dental Air and Water Supply Units |
|
| Processes Affected: |
| 510(K), PMA, IDE, HDE, PDP, Quality System Regulation |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard and any annexes. Data from the test methods in the standard is needed. Additional testing may be necessary for some products. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.6640 |
Unit, Operative Dental |
Class 1 |
EIA |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Sheena Green |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2540 |
| Silver Spring MD 20993 |
| 301/796-6279 |
| Email: sheena.green@fda.hhs.gov |
|
|
