FDA.reportPublic FDA data

CHEMFIL ROCK

Primary DI
D010606065901
Brand
CHEMFIL ROCK
Company
Dentsply De Trey GmbH
Model
60606590
Catalog number
60606590
Device description
CHEMFIL ROCK INTRO KIT is a high-strength zinc-reinforced glass ionomer restorative in capsule delivery that can be bulk placed and is self cure setting. The capsule extruder is used for the extrusion and direct application of the capsules. With its supporting accessory (Capsule Extruder) it can be classified as a convenience kit.
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
D010606065901PrimaryHIBCC0

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
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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D010644500201SMARTLITE FOCUS64450020644500202017-03-16
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D0106420160TPH Spectra ST6420166420162025-12-11
D01060620118NA0AH Plus Jet Endodontic Sealer Syringe Refill60620118NA60620118NA2025-03-31
D010606659001Compules Tips Gun60665900606659002023-08-10
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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
D0106425410TPH Spectra ST6425416425412024-02-27

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Primary DI, Brand, Company table
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