FDA.report

DENTSPLY TruByte® Characterized Lucitone® Denture Base Resin

Primary DI
D0026860431
Brand
DENTSPLY TruByte® Characterized Lucitone® Denture Base Resin
Company
DENTSPLY INTERNATIONAL INC.
Model
686043
Catalog number
686043
Device description
DENTSPLY TruByte® Characterized Lucitone® Denture Base Resin - Single Unit Packaging 50 Unit Pkg Reddish Pink
Published
2016-09-23
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
false

Related Records

Contact Domains

Product Codes

CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026860431PrimaryHIBCC0

GMDN Terms

TermDefinition
Medicine bottleAn empty glass or plastic container, typically with a relatively narrow neck and a lid/cap, intended to be used to store medication so that it retains its viability. This is typically a single-patient device that is reused until the contents are exhausted.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature16 Degrees Celsius27 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags

DUNS number
083235549
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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