FDA.report

Faci Form

Primary DI
D798FFL0
Brand
Faci Form
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
FFL
Catalog number
FFL
Device description
Faci Forms are intended for use as a mold for the creation of temporary, prosthetic composite teeth. This is a pack of 5 medium and 5 large for the left side of the arch. Size #12.
Published
2016-08-08
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
true

Related Records

Product Codes

CodeName
ECPInstrument, Ligature Tucking, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECPInstrument, Ligature Tucking, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798FFL0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental veneer, custom-madeA custom-made facial restoration of ceramic or polymer-based material (resin) used in aesthetic dentistry to correct the facial surface of a tooth. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in ambient conditions.

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags

DUNS number
113170088
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
false
Sterilization required before use
false

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