Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3850](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3850) → EKM — Gutta-Percha # EKM · Gutta-Percha _Dental · 21 CFR 872.3850 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM ## Overview - **Product Code:** EKM - **Device Name:** Gutta-Percha - **Regulation:** [21 CFR 872.3850](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3850) - **Device Class:** 1 - **Review Panel:** [Dental](/submissions/DE) ## 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](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K073369.md) | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg. Co., Inc. | Feb 27, 2008 | SESE | | [K070246](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K070246.md) | DOWN PAK | Endo Twinn B.V. | Feb 16, 2007 | SESE | | [K051573](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K051573.md) | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | Dr. Howard Martin, P.A. | Jun 26, 2006 | SESE | | [K042870](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K042870.md) | ENDO TWINN | Endo Twinn B.V. | Jan 11, 2005 | SESE | | [K023819](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K023819.md) | FIBERFILL SGP | Pentron Clinical Technologies | Mar 26, 2003 | SESE | | [K971641](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K971641.md) | ANTIBACTERIAL GUTTA PERCHA | Dr. Howard Martin, P.A. | Jul 21, 1997 | SESE | | [K970134](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K970134.md) | THERMAPREP PLUS OVEN | Tulsa Dental Products, Ltd. | Mar 21, 1997 | SESE | | [K931742](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K931742.md) | INJECT-R FILL | Union Broach, Div. Moyco Industries, Inc. | May 27, 1993 | SESE | | [K924825](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K924825.md) | MICRODOSE RC-EZ | Unicep | Mar 5, 1993 | SESE | | [K915243](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K915243.md) | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Analytic Technology | Jan 21, 1992 | SESE | | [K910224](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K910224.md) | THERMAPREP | Tulsa Dental Products, Ltd. | Mar 29, 1991 | SESE | | [K900986](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K900986.md) | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | Nov 13, 1990 | SESE | | [K896663](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K896663.md) | ENDO-PREP | Pulpdent Corp. | Feb 14, 1990 | SESE | | [K881139](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K881139.md) | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | Apr 7, 1988 | SESE | | [K863638](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K863638.md) | GUTTA PERCHA POINTS | Endodent, Inc. | Oct 30, 1986 | SESE | | [K863411](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K863411.md) | GUTTA PERCHA | Endodent, Inc. | Oct 30, 1986 | SESE | | [K862129](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K862129.md) | SET CANAL SEALER PASTE | Endo Technic Corp. | Jul 22, 1986 | SESE | | [K850863](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K850863.md) | ULTRAFIL-LT (GUTTA PERCHA) | The Hygenic Corp. | Apr 16, 1985 | SESE | | [K832654](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K832654.md) | HEATED GUTTA PERCHA DELIVERY SYSTEM | Unitek Corp. | Sep 26, 1983 | SESE | | [K830115](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM/K830115.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EKM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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