GUTTAFLOW
Resin, Root Canal Filling
COLTENE/WHALEDENT GMBH & CO. KG
The following data is part of a premarket notification filed by Coltene/whaledent Gmbh & Co. Kg with the FDA for Guttaflow.
Pre-market Notification Details
| Device ID | K032662 |
| 510k Number | K032662 |
| Device Name: | GUTTAFLOW |
| Classification | Resin, Root Canal Filling |
| Applicant | COLTENE/WHALEDENT GMBH & CO. KG 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223 |
| Contact | Henry J Vogelstein |
| Correspondent | Henry J Vogelstein COLTENE/WHALEDENT GMBH & CO. KG 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2003-11-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E165600195290 | K032662 | 000 |
| E165600137020 | K032662 | 000 |
| E165600137040 | K032662 | 000 |
| E165600137060 | K032662 | 000 |
| E165600137090 | K032662 | 000 |
| E165600137100 | K032662 | 000 |
| E165600137110 | K032662 | 000 |
| E165600137130 | K032662 | 000 |
| E165600137450 | K032662 | 000 |
| E165600137460 | K032662 | 000 |
| E165600137010 | K032662 | 000 |
Trademark Results [GUTTAFLOW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUTTAFLOW 79369300 not registered Live/Pending |
Coltène/Whaledent AG 2023-02-27 |
 GUTTAFLOW 76492053 2794487 Live/Registered |
COLTENE/WALEDENT GMBH & CO. KG 2003-02-21 |
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