EnvoyCem®

Contact Domains#

Code, Name table
Code	Name
NEA	Cement, Ear, Nose And Throat

Code, Device, Specialty table
Code	Device	Specialty	Class
NEA	Cement, Ear, Nose And Throat	Dental	2

Submission, Supplement table
Submission	Supplement
K080032	000

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
K080032	000	ENVOYCEM, MODEL 1640	Envoy Medical Corporation	2008-02-28	NEA

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00812282020375	Primary	GS1	0

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00812282020375	00812282020375	812282020375	0812282020375

Term, Definition table
Term	Definition
Glass ionomer dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Type, Low, High table
Type	Low	High	Condition
Handling Environment Temperature	0 Degrees Celsius	50 Degrees Celsius
Special Storage Condition, Specify	0	0	Fragile, Handle with Care
Storage Environment Temperature	0 Degrees Celsius	50 Degrees Celsius

Method table
Method

Phone, Email table
Phone	Email
6513618000	info@envoymedical.com

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00812282020009	Esteem® Sensor	7010	907010-001	2014-09-24
00812282020016	Esteem® Driver	7504	907504-001	2014-09-24
00812282020023	Esteem® Driver	7504	907504-003	2014-09-24
00812282020030	Esteem® Driver	7510	907510-001	2014-09-24
00812282020047	Esteem® Sensor	7004	907004-001	2014-09-24
00812282020054	Esteem® Sensor	7004	907004-003	2014-09-24
00812282020207	Esteem® Sound Processor	2001	902001-002	2014-09-24
00812282020214	Esteem® Sound Processor	2001	902001-003	2014-09-24
00812282020603	Esteem MedCem	1610	901610-301	2018-07-17
10812282020228	Esteem® Bone Screws	1790	901790-001	2014-09-24
10812282020235	Esteem® Glasscock Stabilizers	1730	901730-002	2014-09-24
10812282020242	Esteem® Tapered Syringe Tips	1725	901725-002	2014-09-24
10812282020518	Esteem® Syringe	1710	701710-002	2014-09-24
10812282020563	Esteem® IS-1 Lead End Cap	1400	701400-001	2014-09-24
20812282020225	Esteem® Bone Screws	1790	701790-002	2014-09-24
00812282020078	Esteem® Personal Programmer	8001	908001-101	2014-09-24
00812282020122	Esteem® Commander™	6001	906011-102	2014-09-24
00812282020139	Esteem® Intraoperative System Analyzer	3001	903200-003	2014-09-24
00812282020146	Esteem® Intraoperative System Analyzer	3001	903200-005	2014-09-24
00812282020160	Esteem® Intraoperative System Analyzer	3001	903001-003	2014-09-24

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
M7379860011	PROCEM	Ototronix, LLC	NEA	2020-12-02
M7379860021	PROCEM	Ototronix, LLC	NEA	2020-12-02
M7379860031	PROCEM	Ototronix, LLC	NEA	2020-12-02
M7379860041	PROCEM	Ototronix, LLC	NEA	2020-12-02
M737P97201	PROCEM	Ototronix, LLC	NEA	2020-12-02
M737P97301	PROCEM	Ototronix, LLC	NEA	2020-12-02
M737P97401	PROCEM	Ototronix, LLC	NEA	2020-12-02
00888233025201	N/A	BIOMET MICROFIXATION, INC	NEA	2020-06-26
M737P97021	PROCEM	Ototronix, LLC	NEA	2015-09-22
00841036141943	OTOMIMIX	BIOMET MICROFIXATION, INC	NEA	2015-09-11