FDA.reportPublic FDA data

Dentronix

Primary DI
D661D7000F0
Brand
Dentronix
Company
DENTRONIX INC
Model
D7000F
Device description
Replacement HEPA Filter
Published
2016-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMHSterilizer, Dry Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMHSterilizer, Dry HeatGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051660000DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMColtene/Whaledent, Inc.2005-08-04KMH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D661D7000F0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dry-heat sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from non-heat sensitive medical devices and related products using dry heat sterilization. It typically includes a treatment chamber with shelves where the devices to be sterilized are placed, usually after cleaning of gross debris; a heat source (e.g., electric heaters); and controls to regulate the time and/or temperature of the procedure. The heat may flow into the chamber either by natural convection or using forced air to accelerate and/or make more uniform the process (e.g., fans, high-speed hot air jets). The device is available in stand-alone (bulk) and tabletop units.

Contacts#

Phone, Email table
PhoneEmail
330-916-7300info@dentronix.com

Regulatory Flags#

DUNS number
085690428
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D661D5000SHT0DentronixD5000S-HT2016-07-15
D661D5000ST0DentronixD5000S-T2016-07-15
D661D7000C0DentronixD7000C2016-07-15
D661D7000CL0DentronixD7000CL2016-07-15
D661D7000MS0DentronixD7000M-S2016-07-15
D661D7000SILVER0DentronixD7000-SILVER2016-07-15
D661D7107010DentronixD7107-012016-07-15
D661DADBL0DentronixDAD-BL2016-07-15
D661DADUL0DentronixDAD-UL2016-07-15
D661DDS70001150DentronixDDS70001152016-07-15
D661DDS70002300DentronixDDS70002302016-07-15
D661DDS7000230K0DentronixDDS7000230K2016-07-15
D661DSSH10DentronixDSSH-12016-07-15
D661600139470Dentronix600139472016-08-18
D661600139540Dentronix600139542016-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B234KMHRHPRO111230V1RH-Pro11-230VCPAC EQUIPMENT, INC.KMH2020-10-01
B234KMHRHPRO9115V3RH-Pro9CPAC EQUIPMENT, INC.KMH2020-10-01
B234KMHRHPRO9115V4RH-Pro9-230VCPAC EQUIPMENT, INC.KMH2020-10-01
M36883751GRAFCOGF HEALTH PRODUCTS, INC.KMH2020-08-24
M36883761GRAFCOGF HEALTH PRODUCTS, INC.KMH2020-08-24
B234KMHRHPRO111115V0RH-Pro11CPAC EQUIPMENT, INC.KMH2019-01-18
B234KMHSD201000115STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD201000230STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD301000115STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHSD301000230STERIDENTCPAC EQUIPMENT, INC.KMH2018-08-31
B234KMHCX6220230V152COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHCX6220230V163COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS2100115V2STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS2100230V0STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS3100115V3STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHSS3100230V1STERISURECPAC EQUIPMENT, INC.KMH2018-08-24
B234KMHCX6000115V161COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-08-23
B234KMHCX6000115V150COX RAPIDHEATCPAC EQUIPMENT, INC.KMH2018-07-31
D661D5000SHT0DentronixDENTRONIX INCKMH2016-07-15
D661D5000ST0DentronixDENTRONIX INCKMH2016-07-15
D661D7000C0DentronixDENTRONIX INCKMH2016-07-15
D661D7000CL0DentronixDENTRONIX INCKMH2016-07-15
D661D7000MS0DentronixDENTRONIX INCKMH2016-07-15
D661D7000SILVER0DentronixDENTRONIX INCKMH2016-07-15
D661D7107010DentronixDENTRONIX INCKMH2016-07-15
D661DADBL0DentronixDENTRONIX INCKMH2016-07-15
D661DADUL0DentronixDENTRONIX INCKMH2016-07-15
D661DDS70001150DentronixDENTRONIX INCKMH2016-07-15
D661DDS70002300DentronixDENTRONIX INCKMH2016-07-15
D661DDS7000230K0DentronixDENTRONIX INCKMH2016-07-15