FDA.reportPublic FDA data

CERASMART®

Primary DI
14548161320030
Brand
CERASMART®
Company
Gc America Inc.
Model
012396
Catalog number
012396
Device description
CERASMART™ 270 12 Cerec A1 HT 5p Block
Published
2022-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, tooth shade, resin
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133824000CERASMARTGC America, Inc.2014-03-14EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14548161320030PrimaryGS10
04548161320033Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454816132003014548161320030
04548161320033045481613200334548161320033

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature39 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(708)597-0900customerservice@gcamerica.com

Regulatory Flags#

DUNS number
005473608
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00386040015243Foundation27-500-10027-500-1002024-03-12
00386040015250Foundation27-500-20027-500-2002024-03-12
14550565002269Cytrans Granules10041295100412952026-03-03
14550565002276Cytrans Granules10041296100412962026-03-03
D047014615Cytrans Granules10041295100412952026-03-03
D047014616Cytrans Granules10041296100412962026-03-03
14548161312134Cytrans Granules0143600143602022-08-12
14548161312141Cytrans Granules0143610143612022-08-12
14548161312158Cytrans Granules0143620143622022-08-12
14548161312165Cytrans Granules0143630143632022-08-12
14548161312172Cytrans Granules0143640143642022-08-12
04548161312137Cytrans Granules100075160143602022-04-01
04548161312144Cytrans Granules100075170143612022-04-01
04548161312151Cytrans Granules100075180143622022-04-01
04548161312168Cytrans Granules100075190143632022-04-01
04548161312175Cytrans Granules100075200143642022-04-01
D0470143601Cytrans Granules100075160143602022-04-01
D0470143611Cytrans Granules100075170143612022-04-01
D0470143621Cytrans Granules100075180143622022-04-01
D0470143631Cytrans Granules100075190143632022-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208477825Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
07615208477832Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-10-19
06942201776305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788100FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788292FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788391FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788483FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788582FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788773FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788780FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788797FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201788971FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789060FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789152FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789169FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789183FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789251FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789350FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789442FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789459FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789541FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201789732FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942201790028FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707625FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707816FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707915FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480707939FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708004FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708011FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17
06942480708103FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-10-17