FDA.reportPublic FDA data

Acrytemp CB A2

Primary DI
EZHIC7002001
Brand
Acrytemp CB A2
Company
ZHERMACK SPA
Model
C700200
Catalog number
C700200
Device description
Dental Composite Material
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZHIC7002001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume50Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius20 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390425597611info@zhermack.com

Regulatory Flags#

DUNS number
432971034
Device count
1
DM 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
EZHIC4016101Elite GlassC401610C4016102016-09-09
08056000372298Dynamic-static Mixing TipsC205530C2055302025-03-28
08056000372304Mixing TipsC202085C2020852025-03-28
08056000372311Mixing TipsC202086C2020862025-03-28
08056000372328Mixing TipsC202090C2020902025-03-28
08056000372465Dynamic-static Mixing TipsC205530C2055302025-03-28
08056000372434Mixing TipsC202085C2020852025-03-28
08056000372441Mixing TipsC202086C2020862025-03-28
08056000372472Mixing TipsC202090C2020902025-03-28
EZHIC3020250hydrogumC302025C3020252016-09-09
EZHIC2007261Occlufast RockC200726C2007262016-09-09
EZHIC2008001Occlufast CadC200800C2008002016-09-09
EZHIC2020201Elite HD+ Monophase Normal SetC202020C2020202016-09-09
EZHIC2020321Elite HD+ Tray Material Fast SetC202032C2020322016-09-09
EZHIC2023201Elite HD+ Maxi Tray Material Fast SetC202320C2023202016-09-09
EZHIC2023301Elite HD+ Maxi Tray Material Fast SetC202330C2023302016-09-09
EZHIC2030000Elite HD+ Putty Soft Normal SetC203000C2030002016-09-09
EZHIC2030021Elite HD+ Putty Soft Normal SetC203002C2030022016-09-09
EZHIC2030100Elite HD+ Putty Soft Fast SetC203010C2030102016-09-09
EZHIC2030121Elite HD+ Putty Soft Fast SetC203012C2030122016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E235DD16A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A35MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL3ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL4MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLMN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16C2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16D3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
00371347023398Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023404Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
00371347023411Advance Dental ProductsThe Atlanta Dental Supply CompanyEBG2026-07-08
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07