EKM

Product Code: EKM

Products Classified as EKM

1225

Gutta-percha

Gutta Percha.

Total Product Life Cycle (TPLC) Devices

1225

Gutta-percha

Gutta Percha.

FDA Consensus Standards

• Gutta-Percha [33455]: 21 CFR §872.3850 🔎
• Gutta-Percha [31718]: 21 CFR §872.3850 🔎

Pre-market Notifications for EKM

K073369	EI DOWNPAK BARRIER SLEEVES	HU-FRIEDY MFG. CO., INC
K070246	DOWN PAK	ENDO TWINN B.V.
K051573	TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)	DR. HOWARD MARTIN, P.A.
K042870	ENDO TWINN	ENDO TWINN B.V.
K023819	FIBERFILL SGP	PENTRON CLINICAL TECHNOLOGIES
K971641	ANTIBACTERIAL GUTTA PERCHA	DR. HOWARD MARTIN, P.A.
K970134	THERMAPREP PLUS OVEN	TULSA DENTAL PRODUCTS, LTD.
K931742	INJECT-R FILL	UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
K924825	MICRODOSE RC-EZ	UNICEP
K915243	TOUCH 'N HEAT MODEL 5002, MODIFICATION	ANALYTIC TECHNOLOGY
K910224	THERMAPREP	TULSA DENTAL PRODUCTS, LTD.
K900986	THERMAFIL ENDODONTIC OBTURATOR	TULSA DENTAL PRODUCTS, LTD.
K896663	ENDO-PREP	PULPDENT CORP.
K881139	THERMAFIL ENDODONTIC OBTURATOR	TULSA DENTAL PRODUCTS, LTD.
K863638	GUTTA PERCHA POINTS	ENDODENT, INC.

Global Unique Device Identification Database

• 00366975004383: Gutta-Percha
• 00366975004376: Gutta-Percha
• 00366975004369: Gutta-Percha
• 00366975004352: Gutta-Percha
• 00366975004345: Gutta-Percha
• 00366975004338: Gutta-Percha
• 00366975004321: Gutta-Percha
• 00366975004314: Gutta-Percha
• 00366975004307: Gutta-Percha
• 00366975004291: Gutta-Percha
• 00366975004284: Gutta-Percha
• 00366975004277: Gutta-Percha
• 00366975004260: Gutta-Percha
• 00366975004253: Gutta-Percha
• 00366975004246: Gutta-Percha

Maude Adverse Events

GUTTAFUSION OBTURATOR OVEN	DENTSPLY VDW GMBH	2018-10-05
SYBRONENDO	SYBRONENDO	2018-06-13
THERMAPREP PLUS OVEN	DENTSPLY MAILLEFER	2018-01-15
PROTAPER UNIVERSAL OBTURATORS	DENTSPLY TULSA DENTAL SPECIALTIES	2017-07-05
GUTTACORE PINK OBTURATOR	DENTSPLY TULSA DENTAL SPECIALTIES	2017-03-31
THERMAPREP 2 OVEN	DENTSPLY MAILLEFER	2017-03-16
GT OBTURATOR	DENTSPLY TULSA DENTAL SPECIALTIES	2016-08-17
GUTTAFUSION PINK OBTURATOR	DENTSPLY VDW GMBH	2016-03-15
GUTTACORE OBTURATOR (PINK)	DENTSPLY TULSA DENTAL SPECIALTIES	2015-11-13
GUTTACORE OBTURATOR (PINK)	DENTSPLY TULSA DENTAL SPECIALTIES	2015-11-13
GUTTAFUSION OBTURATORS	DENTSPLY VDW GMBH	2015-08-12
PROTAPER UNIVERSAL OVEN	DENTSPLY TULSA DENTAL SPECIALTIES	2015-07-16
GUTTACORE OBTURATOR OVEN	DENTSPLY TULSA DENTAL SPECIALTIES	2015-07-09
GUTTACORE OBTURATORS	DENTSPLY TULSA DENTAL SPECIALTIES	2015-06-18
REALSEAL	SYBRONENDO	2015-04-17
GUTTACORE OBTURATOR (PINK)	DENTSPLY TULSA DENTAL SPECIALTIES	2015-04-02
REALSEAL	SYBRONENDO	2014-11-19
REALSEAL	SYBRONENDO	2014-11-07
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL	SYBRONENDO	2014-10-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09
REALSEAL POINTS	SYBRONENDO	2014-09-09