FDA.report

Radica®

Primary DI
D0019081230
Brand
Radica®
Company
Dentsply International Inc.
Model
Dentin B4
Catalog number
908123
Published
2016-09-21
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

Product Codes

CodeName
EBDCOATING, FILLING MATERIAL, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0019081230PrimaryHIBCC0

GMDN Terms

TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Device Sizes

TypeValueUnit
Weight5Gram

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)243-1942Prosthetics-Regulatory@dentsply.com

Regulatory Flags

DUNS number
606173334
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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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