FDA.report

SmileGoods Easy Flex Floss Threaders

Primary DI
00723896010969
Brand
SmileGoods Easy Flex Floss Threaders
Company
PRACTICON, INC.
Model
JSC014
Catalog number
71-09877
Device description
Get the same high quality of leading brands at half the price with SmileGoods Easy Flex Floss Threaders. Large loop works with all floss types to make cleaning around bridges, braces, and implants easier than ever. 10 threaders per clear plastic case,
Published
2018-07-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
JESFloss, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
JESFloss, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00723896010969PackageGS18In Commercial Distribution
00723896010952PrimaryGS10
00723896008089Unit of UseGS10

GMDN Terms

TermDefinition
Dental flossA string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119193803
Device count
72
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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