Setter, Band, Orthodontic
Regulation 872.4565
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ECR
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentauraum, Inc. | 1 | 0 |
| Essential Dental Systems, Inc. | 1 | 0 |
| Ormco Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 23, 1995 | K951776 | BAND SEATER Ormco Corp. | ECR |
| Feb 3, 1994 | K935156 | DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS Dentauraum, Inc. | ECR |
| Sep 27, 1984 | K843018 | FLEXI-POST Essential Dental Systems, Inc. | ECR |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.