The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Nti Clenching Suppression System.
| Device ID | K981546 |
| 510k Number | K981546 |
| Device Name: | NTI CLENCHING SUPPRESSION SYSTEM |
| Classification | Mouthguard, Prescription |
| Applicant | HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman HERAEUS KULZER, INC. 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | MQC |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-30 |
| Decision Date | 1998-07-15 |