FLEXITIME BITE
Material, Impression
HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION
The following data is part of a premarket notification filed by Heraeus Kulzer, Inc., Dental Products Division with the FDA for Flexitime Bite.
Pre-market Notification Details
| Device ID | K082591 |
| 510k Number | K082591 |
| Device Name: | FLEXITIME BITE |
| Classification | Material, Impression |
| Applicant | HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Contact | Cheryl V Zimmerman |
| Correspondent | Cheryl V Zimmerman HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION 4315 SOUTH LAFAYETTE BLVD. South Bend, IN 46614 -2517 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2008-12-05 |
| Summary: | summary |
Trademark Results [FLEXITIME BITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLEXITIME BITE 76692796 3656250 Live/Registered |
KULZER GMBH 2008-09-12 |
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