FDA.report

SmileGoods Premium (PTFE) Dental Floss Mint

Primary DI
00723896010303
Brand
SmileGoods Premium (PTFE) Dental Floss Mint
Company
PRACTICON, INC.
Model
FL-641
Catalog number
70-45206
Device description
Each pocket-sized dispenser contains 12 yards of PTFE floss. See-through plastic dispensers are color-coded by style and flavor. 1 5/8" tall. 72 dispensers per case.
Published
2018-07-18
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
00723896010303PackageGS116In Commercial Distribution
00723896010297PrimaryGS10
00723896004159Unit 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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