EKM · Gutta-Percha
Dental · 21 CFR 872.3850 · Class 1
Overview
| Product Code | EKM |
|---|---|
| Device Name | Gutta-Percha |
| Regulation | 21 CFR 872.3850 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073369 | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg. Co., Inc. | Feb 27, 2008 | SESE |
| K070246 | DOWN PAK | Endo Twinn B.V. | Feb 16, 2007 | SESE |
| K051573 | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | Dr. Howard Martin, P.A. | Jun 26, 2006 | SESE |
| K042870 | ENDO TWINN | Endo Twinn B.V. | Jan 11, 2005 | SESE |
| K023819 | FIBERFILL SGP | Pentron Clinical Technologies | Mar 26, 2003 | SESE |
| K971641 | ANTIBACTERIAL GUTTA PERCHA | Dr. Howard Martin, P.A. | Jul 21, 1997 | SESE |
| K970134 | THERMAPREP PLUS OVEN | Tulsa Dental Products, Ltd. | Mar 21, 1997 | SESE |
| K931742 | INJECT-R FILL | Union Broach, Div. Moyco Industries, Inc. | May 27, 1993 | SESE |
| K924825 | MICRODOSE RC-EZ | Unicep | Mar 5, 1993 | SESE |
| K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Analytic Technology | Jan 21, 1992 | SESE |
| K910224 | THERMAPREP | Tulsa Dental Products, Ltd. | Mar 29, 1991 | SESE |
| K900986 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | Nov 13, 1990 | SESE |
| K896663 | ENDO-PREP | Pulpdent Corp. | Feb 14, 1990 | SESE |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | Apr 7, 1988 | SESE |
| K863638 | GUTTA PERCHA POINTS | Endodent, Inc. | Oct 30, 1986 | SESE |
| K863411 | GUTTA PERCHA | Endodent, Inc. | Oct 30, 1986 | SESE |
| K862129 | SET CANAL SEALER PASTE | Endo Technic Corp. | Jul 22, 1986 | SESE |
| K850863 | ULTRAFIL-LT (GUTTA PERCHA) | The Hygenic Corp. | Apr 16, 1985 | SESE |
| K832654 | HEATED GUTTA PERCHA DELIVERY SYSTEM | Unitek Corp. | Sep 26, 1983 | SESE |
| K830115 | PAPER POINTS | North Pacific Dental, Inc. | Mar 1, 1983 | SESE |
Top Applicants
- Tulsa Dental Products, Ltd. — 4 clearances
- North Pacific Dental, Inc. — 2 clearances
- Endodent, Inc. — 2 clearances
- Endo Twinn B.V. — 2 clearances
- Dr. Howard Martin, P.A. — 2 clearances
