The following data is part of a premarket notification filed by Indigenous Peoples Technology And Education Center with the FDA for I-tec Portable Dental Operatory.
| Device ID | K040153 |
| 510k Number | K040153 |
| Device Name: | I-TEC PORTABLE DENTAL OPERATORY |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | INDIGENOUS PEOPLES TECHNOLOGY AND EDUCATION CENTER 10575 SW 147TH CIRCLE Dunnellon, FL 34432 |
| Contact | Jesse Saint |
| Correspondent | Jesse Saint INDIGENOUS PEOPLES TECHNOLOGY AND EDUCATION CENTER 10575 SW 147TH CIRCLE Dunnellon, FL 34432 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-23 |
| Decision Date | 2004-05-21 |