FDA.reportPublic FDA data

Sealing Cap (Size 8)

Primary DI
00858395006400
Brand
Sealing Cap (Size 8)
Company
SONENDO, INC.
Model
FG-001-00008
Catalog number
GW-MOL-SP08
Device description
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.
Published
2018-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858395006400PrimaryGS10
00858395006134Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858395006400008583950064008583950064000858395006400
00858395006134008583950061348583950061340858395006134

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure69.7 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8447663636info@sonendo.com

Regulatory Flags#

DUNS number
828894373
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810209420031FlowLogic AssertFG-016-00007-03FLG10C06212025-12-26
00810209420451FlowLogic AssertFG-016-00006-63FLG10C04312025-12-26
00810209420468FlowLogic AssertFG-016-00007-33FLG10C06252025-12-26
00810209420475FlowLogic AssertFG-016-00007-63FLG10C06312025-12-26
00810209420536FlowLogic AssertFG-016-00006-65FLG15C04312025-12-26
00810209420543FlowLogic AssertFG-016-00007-05FLG15C06212025-12-26
00810209420550FlowLogic AssertFG-016-00007-35FLG15C06252025-12-26
00810209420567FlowLogic AssertFG-016-00007-65FLG15C06312025-12-26
00810209420628FlowLogic AssertFG-016-00006-66FLG20C04312025-12-26
00810209420635FlowLogic AssertFG-016-00007-06FLG20C06212025-12-26
00810209420642FlowLogic AssertFG-016-00007-36FLG20C06252025-12-26
00810209420659FlowLogic AssertFG-016-00007-66FLG20C06312025-12-26
00810209420680FlowLogic AssertFG-016-00006-67FLG25C04312025-12-26
00810209420697FlowLogic AssertFG-016-00007-07FLG25C06212025-12-26
00810209420703FlowLogic AssertFG-016-00007-37FLG25C06252025-12-26
00810209420710FlowLogic AssertFG-016-00007-67FLG25C06312025-12-26
00810209420734FlowLogic AssertFG-016-00006-38FLG30C04252025-12-26
00810209420741FlowLogic AssertFG-016-00006-68FLG30C04312025-12-26
00810209420758FlowLogic AssertFG-016-00007-08FLG30C06212025-12-26
00810209420765FlowLogic AssertFG-016-00007-38FLG30C06252025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDELC2026-09-24
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06979865810052JAS PexDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDELC2026-09-24
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07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170325PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
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J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.ELC2026-06-11