FDA.report

Safco Fluora Trays

Primary DI
D72310273170
Brand
Safco Fluora Trays
Company
SAFCO DENTAL SUPPLY CO.
Model
1027317
Catalog number
1027317
Device description
Safco Fluora trays pedo aqua 100/bag
Published
2022-11-21
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
KMTTRAY, FLUORIDE, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
KMTTray, Fluoride, DisposableDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D72310273173PrimaryHIBCC0
D72310273170Unit of UseHIBCC0

GMDN Terms

TermDefinition
Teeth whitening trayA custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020417380
Device count
100
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
false
Sterilization required before use
false

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