Molar Matrix GW-MOL-OMTX

GUDID 00858395006011

The Molar Matrix is used to form a flat surface on the occlusal surface of a tooth by spreading a bite registration material into the surface irregularities of the crown.

SONENDO, INC.

Dental delivery system instrument unit, electric
Primary Device ID00858395006011
NIH Device Record Keyc13a4503-23ab-43b6-9751-952cac085f22
Commercial Distribution StatusIn Commercial Distribution
Brand NameMolar Matrix
Version Model NumberFG-001-00003
Catalog NumberGW-MOL-OMTX
Company DUNS828894373
Company NameSONENDO, INC.
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8447663636
Emailinfo@sonendo.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858395006011 [Primary]
GS100858395006165 [Unit of Use]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

On-Brand Devices [Molar Matrix]

00858395006448The Molar Matrix is used to form a flat surface on the occlusal surface of a tooth by spreading
00858395006011The Molar Matrix is used to form a flat surface on the occlusal surface of a tooth by spreading

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