Gutta-Percha
FDA product code EKM · Class I (low risk) · 21 CFR 872.3850 · Dental
23510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Tulsa Dental Products, Ltd. 4
- Analytic Technology 2
- North Pacific Dental, Inc. 2
- Endodent, Inc. 2
- Dr. Howard Martin, P.A. 2
- Endo Twinn B.V. 2
- U.S. Shizai Corp. 1
- Unitek Corp. 1
- The Hygenic Corp. 1
- Endo Technic Corp. 1
- Pulpdent Corp. 1
- Unicep 1
- Union Broach, Div. Moyco Industries, Inc. 1
- Pentron Clinical Technologies 1
- Hu-Friedy Mfg. Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073369 | Ei Downpak Barrier SleevesEKM · Traditional | Hu-Friedy Mfg. Co., Inc. | 02/27/2008SE |
| K070246 | Down PakEKM · Special | Endo Twinn B.V. | 02/16/2007SE |
| K051573 | TGP (Gutta Percha Containing Tetracycline or Doxycycline)EKM · Traditional | Dr. Howard Martin, P.A. | 06/26/2006SE |
| K042870 | Endo TwinnEKM · Traditional | Endo Twinn B.V. | 01/11/2005SE |
| K023819 | Fiberfill SGPEKM · Traditional | Pentron Clinical Technologies | 03/26/2003SE |
| K971641 | Antibacterial Gutta PerchaEKM · Traditional | Dr. Howard Martin, P.A. | 07/21/1997SE |
| K970134 | Thermaprep Plus OvenEKM · Traditional | Tulsa Dental Products, Ltd. | 03/21/1997SE |
| K931742 | Inject-R FillEKM · Traditional | Union Broach, Div. Moyco Industries, Inc. | 05/27/1993SE |
| K924825 | Microdose Rc-EzEKM · Traditional | Unicep | 03/05/1993SE |
| K915243 | Touch 'N Heat Model 5002, ModificationEKM · Traditional | Analytic Technology | 01/21/1992SE |
| K910224 | ThermaprepEKM · Traditional | Tulsa Dental Products, Ltd. | 03/29/1991SE |
| K900986 | Thermafil Endodontic ObturatorEKM · Traditional | Tulsa Dental Products, Ltd. | 11/13/1990SE |
| K896663 | Endo-PrepEKM · Traditional | Pulpdent Corp. | 02/14/1990SE |
| K881139 | Thermafil Endodontic ObturatorEKM · Traditional | Tulsa Dental Products, Ltd. | 04/07/1988SE |
| K863638 | Gutta Percha PointsEKM · Traditional | Endodent, Inc. | 10/30/1986SE |
| K863411 | Gutta PerchaEKM · Traditional | Endodent, Inc. | 10/30/1986SE |
| K862129 | Set Canal Sealer PasteEKM · Traditional | Endo Technic Corp. | 07/22/1986SE |
| K850863 | Ultrafil-Lt (Gutta Percha)EKM · Traditional | The Hygenic Corp. | 04/16/1985SE |
| K832654 | Heated Gutta Percha Delivery SystemEKM · Traditional | Unitek Corp. | 09/26/1983SE |
| K830115 | Paper PointsEKM · Traditional | North Pacific Dental, Inc. | 03/01/1983SE |
| K830114 | Gutta Percha PointsEKM · Traditional | North Pacific Dental, Inc. | 03/01/1983SE |
| K823486 | Touch-N-Heat Model 5001EKM · Traditional | Analytic Technology | 01/18/1983SE |
| K820639 | Obturation System KitEKM · Traditional | U.S. Shizai Corp. | 04/09/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1083-2016 Class II | TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a…Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic… | Ormco/Sybronendo | 02/08/2016Terminated |
| Z-0160-2012 | Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to…The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled. | Ormco Corporation | 09/09/2010Terminated |
| Z-0488-2010 | Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003…The recall was initiated because during the manufacturing process of the affected units, the molding process… | Sybronendo | 10/27/2009Terminated |