FDA.reportPublic FDA data

CHEMFIL ROCK

Primary DI
D010606065951
Brand
CHEMFIL ROCK
Company
Dentsply De Trey GmbH
Model
60606595
Catalog number
60606595
Device description
CHEMFIL ROCK CONTRAST WHITE is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting.
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER
EBFMATERIAL, TOOTH SHADE, RESIN
EJKLINER, CAVITY, CALCIUM HYDROXIDE
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2
EBFMaterial, Tooth Shade, ResinDental2
EJKLiner, Cavity, Calcium HydroxideDental2
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D010606065951PrimaryHIBCC0
D010606065950Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Total Volume0.12Milliliter
Weight442Milligram

Regulatory Flags#

DUNS number
315471722
Device count
50
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D01060620110N1AH Plus Endodontic Sealer60620110N60620110N2026-08-26
D01060620110NA1AH Plus Endodontic Sealer60620110NA60620110NA2025-03-31
D01060620118NA1AH Plus Jet Endodontic Sealer Syringe Refill60620118NA60620118NA2025-03-31
D010644500401SmartLite Focus64450040644500402020-12-16
D01060620115NA1AH Plus Jet Endodontic Sealer Starter Kit60620115NA60620115NA2025-03-31
D010644500201SMARTLITE FOCUS64450020644500202017-03-16
D010644500211SmartLite Focus64450021644500212020-12-16
D010644500501SmartLite Focus64450050644500502020-12-16
D010644500701SmartLite Focus64450070644500702020-12-16
D0106420161TPH Spectra ST6420166420162025-12-11
D0106420160TPH Spectra ST6420166420162025-12-11
D01060620118NA0AH Plus Jet Endodontic Sealer Syringe Refill60620118NA60620118NA2025-03-31
D010606659001Compules Tips Gun60665900606659002023-08-10
D0106425401TPH Spectra ST6425406425402024-02-27
D0106425411TPH Spectra ST6425416425412024-02-27
D0106425421TPH Spectra ST6425426425422024-02-27
D0106425431TPH Spectra ST6425436425432024-02-27
D0106425441TPH Spectra ST6425446425442024-02-27
D0106425451TPH Spectra ST6425456425452024-02-27
D0106425400TPH Spectra ST6425406425402024-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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