510(k) K863638
- Device
- GUTTA PERCHA POINTS
- Applicant
- ENDODENT, INC.
- 510(k) number
- K863638
- Product code
- EKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-30
- Date received
- 1986-09-17
- Regulation
- 872.3850
- Classification name
- Gutta-percha
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAX LENZ
- Address
- 135 E. Chestnut Ave. Suite 5, P.O. Box 1606 Monrovia CA US 91016 91016
FDA Registration Numbers#
- 3005176727
- 9616142
- 3011713204
- 3017181138
- 2245654
- 3014334038
- 3013538161
- 3011215096
- 3025436467
- 3015060216
- 3011434305
- 2086043
- 2433629
- 3043750057
- 3031582434
- 3004133229
- 3008857765
- 3014159752
- 3043648115
- 3017604
- 3012628066
- 3017941947
- 2436986
- 3001644167
- 3005558160
- 3011554142
- 3021023132
- 3002957626
- 3009171220
- 3015272949
- 3042866301
- 8031010
- 3012627824
- 2024980
- 8010468
- 3038718579
- 9615399
- 3001082453
- 3006621310
- 3010864832
- 3027343382
- 3008249935
- 3044175603
- 8040288
- 8030607
- 3006444232
- 3009431661
- 3011276344
- 3015526995
- 2320721
- 8020994
- 1032227
- 3023816720
- 3008370577
- 3003418325
- 1836161
- 3015136927
- 8010629
- 8010414
- 3016170492
- 3010598169
- 3021245739
- 3007663058
- 3017910185
- 3008887731
- 3005972890
- 3006186796
- 3042283835
- 2183301
- 3008352964
- 3000303964
- 3012494290
- 1718912
- 2081055
- 3015060193
- 9681254
- 9681748
- 3014326245
- 3006113314
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EKM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073369 | EI DOWNPAK BARRIER SLEEVES | Hu-Friedy Mfg. Co., Inc. | 2008-02-27 |
| K070246 | DOWN PAK | Endo Twinn B.V. | 2007-02-16 |
| K051573 | TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) | Dr. Howard Martin, P.A. | 2006-06-26 |
| K042870 | ENDO TWINN | Endo Twinn B.V. | 2005-01-11 |
| K023819 | FIBERFILL SGP | Pentron Clinical Technologies | 2003-03-26 |
| K971641 | ANTIBACTERIAL GUTTA PERCHA | Dr. Howard Martin, P.A. | 1997-07-21 |
| K970134 | THERMAPREP PLUS OVEN | Tulsa Dental Products, Ltd. | 1997-03-21 |
| K931742 | INJECT-R FILL | Union Broach, Div. Moyco Industries, Inc. | 1993-05-27 |
| K924825 | MICRODOSE RC-EZ | Unicep | 1993-03-05 |
| K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Analytic Technology | 1992-01-21 |
| K910224 | THERMAPREP | Tulsa Dental Products, Ltd. | 1991-03-29 |
| K900986 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1990-11-13 |
| K896663 | ENDO-PREP | Pulpdent Corp. | 1990-02-14 |
| K881139 | THERMAFIL ENDODONTIC OBTURATOR | Tulsa Dental Products, Ltd. | 1988-04-07 |
| K863411 | GUTTA PERCHA | Endodent, Inc. | 1986-10-30 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases