Sealing Cap (Size 5) GW-MOL-SP05

GUDID 00858395006370

Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.

SONENDO, INC.

Dental delivery system instrument unit, electric
Primary Device ID00858395006370
NIH Device Record Key3456b063-63c4-4b10-87b0-7808d981394b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSealing Cap (Size 5)
Version Model NumberFG-001-00005
Catalog NumberGW-MOL-SP05
Company DUNS828894373
Company NameSONENDO, INC.
Device Count10
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 HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100858395006103 [Unit of Use]
GS100858395006370 [Primary]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-05-25
Device Publish Date2018-04-24

On-Brand Devices [Sealing Cap (Size 5)]

00858395006370Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure I
00858395006035Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure I

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