FDA.reportPublic FDA data

Posterior Cleanflow Matrices

Primary DI
00858395006745
Brand
Posterior Cleanflow Matrices
Company
SONENDO, INC.
Model
FG-013-00007
Catalog number
GW-PST-OMTX
Device description
Posterior Cleanflow Matrices (10 Pack)
Published
2022-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00858395006738PrimaryGS10
00858395006745Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858395006738008583950067388583950067380858395006738
00858395006745008583950067458583950067450858395006745

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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07630392912648BioSonicDent4You AGELC2026-04-06
07613353352356GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-24
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.ELC2026-02-16
10889950154066PWR AirHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154080HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154103HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
07613353335113PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-21
07613353341404PiezonE.M.S. Electro Medical Systems S.A.ELC2025-10-21
07613353257224AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353257323AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353257576AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353258061AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2025-10-20
10810000520630Parkell®PARKELL, INC.ELC2023-10-20
10810000521552Parkell®PARKELL, INC.ELC2023-10-20
J021303230001Proxeo ULTRA PB-510W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303240001Proxeo ULTRA PB-520W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303250001Proxeo ULTRA PB-530W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303260001Proxeo ULTRA Handpiece PB-5 LW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303270001Proxeo ULTRA Handpiece PB-5 L QW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303280001Proxeo ULTRA Handpiece PB-5 L SW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303440001APP-HC-03-XX-00 (Head Controller)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303470001IFB-DC-CO.CO-HS-00 (Interface Board)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303480001RFB-03-0200-00 (Rectifier-Board)W & H Dentalwerk Bürmoos GmbHELC2023-07-19