FDA.report

Health-Tec/DHP Fluoride Trays

Primary DI
D773950100541
Brand
Health-Tec/DHP Fluoride Trays
Company
Dental Health Products Inc
Model
950-10054
Catalog number
950-10054
Device description
Health-Tec/DHP Fluoride Trays Dual Arch Small Yellow 100/bag
Published
2022-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KMTTray, Fluoride, Disposable

Product Code Classifications

CodeDeviceSpecialtyClass
KMTTray, Fluoride, DisposableDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D773950100541PrimaryHIBCC0

GMDN Terms

TermDefinition
Fluoride gel trayA device typically made of styrofoam that is used to apply fluoride topically to the teeth. The device is designed to conform to the human mouth; a patient bites down on the device after it has been filled with a fluoride gel or solution for application.

Sterilization Methods

Method

Regulatory Flags

DUNS number
623191194
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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D7739705220140Health-Tec/DHP Disposable Prophy Angles970-522014970-5220142022-11-28
D773970522140Health-Tec/DHP Disposable Prophy Angles970-522114970-5221142022-11-28
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D7739705225140Health-Tec/DHP Disposable Prophy Angles970-522514970-5225142022-11-28
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D773800100020Health-Tec/DHP Matrix Bands800-10002800-100022022-11-10

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