FDA.report

Pontic

Primary DI
D746EPOO4G1
Brand
Pontic
Company
RAINTREE ESSIX INC.
Model
EPOO4-G
Catalog number
EPOO4-G
Device description
6pc Pontic Set - Gray
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ELMDenture, plastic, teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D746EPOO4G1PrimaryHIBCC0
D746EPOO4G0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental shaded pontic kitA collection of devices intended to be used to produce artificial tooth veneers (shaded pontics) typically inside clear plastic custom-made teeth aligners (retainer-style orthodontic appliances). This is used to create the appearance of teeth inside the aligner to cover spaces where teeth may be missing for aesthetic purposes during treatment to realign teeth. The contents of the device may include polymer-based materials, dispenser gun, mixing tips, applicator brushes and practice aligner.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)883-8733sales@essix.com

Regulatory Flags

DUNS number
801157132
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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D746825701Thermoplier®82570825702016-09-24
D746825901Thermoplier®82590825902016-09-24
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