The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Orthopantomograph 100.
| Device ID | K912893 |
| 510k Number | K912893 |
| Device Name: | ORTHOPANTOMOGRAPH 100 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland, FI |
| Contact | Pekka Marttinen |
| Correspondent | Pekka Marttinen INSTRUMENTARIUM CORP. TEOLLISUUSKATU 27 00510 HELSINKI 51 Finland, FI |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-01 |
| Decision Date | 1991-11-05 |