FDA.reportPublic FDA data

SoftFlow

Primary DI
08806145484031
Brand
SoftFlow
Company
DENTOS Inc.
Model
SF-W
Published
2019-02-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EGDWax, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806145484031PrimaryGS10
08806145484871Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806145484031088061454840318806145484031
08806145484871088061454848718806145484871

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance relief materialA device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or silicone material that is easy to manipulate with the fingers in order to cover the offending protrusions of the orthodontic appliance that are causing irritations in the patient's mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688355973
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
08806145440129Orthodontic DriverLHD-B+DT-L2025-05-02
08806145440136Orthodontic DriverLHD-B+DT-S2025-05-02
08806145440143Orthodontic DriverNLHD+ST-L2025-05-02
08806145440150Orthodontic DriverNLHD+ST-S2025-05-02
08806145440167Orthodontic DriverNLHD-S+ST-L2025-05-02
08806145440174Orthodontic DriverNLHD-S+ST-S2025-05-02
08806145484086Orthodontic DriverNLHD-S2025-05-02
08806145484895Plier, OrthodonticNTDP-T2025-05-02
08806145484901Plier, OrthodonticNTDP-S2025-05-02
08806145484918Plier, OrthodonticCBRP2025-05-02
08806145455192Orthodontic BracketMTB-12018-09-14
08806145455208Orthodontic BracketMTB-22018-09-14
08806145455215Orthodontic BracketTLB-L2018-09-14
08806145455222Orthodontic BracketTLB-U2018-09-14
08806145471352Orthodontic Bracket2in1-U-122018-06-08
08806145471369Orthodontic Bracket2in1-U-32018-06-08
08806145471376Orthodontic Bracket2in1-U-4572018-06-08
08806145471383Orthodontic Bracket2in1-U-62018-06-08
08806145471390Orthodontic Bracket2in1-L-1232018-06-08
08806145471406Orthodontic Bracket2in1-L-4572018-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479203324RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479203331RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479200552RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
00840479200569RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
06978785665070InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-12-08
10190707193215Orthosil™Ortho Organizers, Inc.EGD2025-10-23
10190707149045Comfort Cover™Ortho Organizers, Inc.EGD2025-10-01
10190707143005Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143012Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143029Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143036Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143043Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143050Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143067Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143074Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143081Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143098Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
E235S3DCR0DentaprintSHOFU DENTAL CORPORATIONEGD2025-08-26
07701126901150Portux 3D Printing Resin CastPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEGD2025-08-11
07701126901228Portux 3D Printing Resin CastPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEGD2025-08-11
00840456207604JMUJMU DENTAL, INCEGD2025-07-15
00840456207611JMUJMU DENTAL, INCEGD2025-07-15
00840456207628JMUJMU DENTAL, INCEGD2025-07-15
00840456207635JMUJMU DENTAL, INCEGD2025-07-15
00840456207642JMUJMU DENTAL, INCEGD2025-07-15
16978785665046InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-07-09
06978785665049InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-07-09
07506338322454ROGSON WAX, MDC Dental MDC DENTALEGD2025-05-16
00190886135498NAG & H Wire Company, Inc.EGD2025-03-31
00190886135559NAG & H Wire Company, Inc.EGD2025-03-31