IQ Dental

Primary DI
00816519020619
Brand
IQ Dental
Company
IQ DENTAL SUPPLY LLC
Model
FP-IQDENT-063
Device description
IQDENT PCA CEMENT 15ML/25GM
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K902635000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K902635000MODIFIED GRANITEC P2 & G2 DENTAL CEMENTSConfi-Dental Products Co.1990-07-10EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816519020619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816519020619008165190206198165190206190816519020619

GMDN Terms#

Term, Definition table
TermDefinition
Zinc polycarboxylate dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830702846
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816519020527IQ DentalFP-IQDENT-0532016-09-19
00816519020534IQ DentalFP-IQDENT-0542016-09-19
00816519020541IQ DentalFP-IQDENT-0552016-09-19
00816519020558IQ DentalFP-IQDENT-0562016-09-19
00816519020688IQ DentalFP-IQDENT-0712016-09-19
00816519020633IQ DentalFP-IQDENT-0652016-09-19
00816519020640IQ DentalFP-IQDENT-0662016-09-19
00816519022354IQ Dental ATI-GG3/32ATI-GG3/322022-12-27
00816519022361IQ Dental ATI-GG4/28ATI-GG4/282022-12-27
00816519022378IQ Dental ATI-GG4/32ATI-GG4/322022-12-27
00816519022385IQ Dental ATI-GG5/28ATI-GG5/282022-12-27
00816519022392IQ Dental ATI-GG5/32ATI-GG5/322022-12-27
00816519022408IQ Dental ATI-GG6/28ATI-GG6/282022-12-27
00816519022415IQ Dental ATI-GG6/32ATI-GG6/322022-12-27
00816519022422IQ Dental ATI-PR1/28ATI-PR1/282022-12-27
00816519022439IQ Dental ATI-PR1/32ATI-PR1/322022-12-27
00816519022446IQ Dental ATI-PR2/28ATI-PR2/282022-12-27
00816519022453IQ Dental ATI-PR2/32ATI-PR2/322022-12-27
00816519022460IQ Dental ATI-PR3/28ATI-PR3/282022-12-27
00816519022477IQ Dental ATI-PR3/32ATI-PR3/322022-12-27

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Primary DI, Brand, Company table
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08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29
08809262959208EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959215EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959222EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809262959239EsCem RMGISpident Co., Ltd.EMA2026-04-20
08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
08809911118512NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
07615208292855Speedcem 100IVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293470SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208293487SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208294965SpeedCEM / SpeedCEM PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2024-10-14
07615208298659Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-10-25
07615208298666Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
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