The following data is part of a premarket notification filed by Anaxdent Gmbh with the FDA for New Outline.
| Device ID | K023079 |
| 510k Number | K023079 |
| Device Name: | NEW OUTLINE |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | ANAXDENT GMBH 1730 PENNSYLVANIA N.W. Washington, DC 20006 |
| Contact | Dvorah Richman |
| Correspondent | Dvorah Richman ANAXDENT GMBH 1730 PENNSYLVANIA N.W. Washington, DC 20006 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-16 |
| Decision Date | 2002-10-30 |