The following data is part of a premarket notification filed by Del Medical Systems Corp. with the FDA for S-53 Introral Dental System.
| Device ID | K962979 |
| 510k Number | K962979 |
| Device Name: | S-53 INTRORAL DENTAL SYSTEM |
| Classification | Drill, Dental, Intraoral |
| Applicant | DEL MEDICAL SYSTEMS CORP. ONE COMMERCE PARK Valhalla, NY 10595 |
| Contact | Karl J Weydig |
| Correspondent | Karl J Weydig DEL MEDICAL SYSTEMS CORP. ONE COMMERCE PARK Valhalla, NY 10595 |
| Product Code | DZA |
| CFR Regulation Number | 872.4130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-31 |
| Decision Date | 1996-09-25 |
| Summary: | summary |