IQ Dental

Primary DI
00816519020633
Brand
IQ Dental
Company
IQ DENTAL SUPPLY LLC
Model
FP-IQDENT-065
Device description
IQDENT TEMP FILLING MATERIAL 29G PINK
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
K915467000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915467000CIMPAT S DENTAL CEMENTSpecialites Septodont1992-02-03EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816519020633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816519020633008165190206338165190206330816519020633

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic dressingA non-sterile viscous material intended to be applied to a prepared root canal to maintain its relative sterility between procedures and to facilitate its healing. It is intended to be placed within the root canal temporarily and sealed with a temporary filling material to prevent repopulation of the canal by bacteria. It is typically a zinc or calcium cement-based material that includes an antimicrobial agent (e.g., pharmaceutical or pH), and sometimes an anti-inflammatory agent, available in a tube or syringe. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830702846
Device count
1

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
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
00816519022484IQ Dental ATI-PR4/28ATI-PR4/282022-12-27

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