FDA.reportPublic FDA data

IQ Dental

Primary DI
00816519021555
Brand
IQ Dental
Company
IQ DENTAL SUPPLY LLC
Model
ZAP-CHCLD
Device description
ZAP-CALCIUM HYDROXIDE CAVITY LINER- DENTIN SHADE
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
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961198000BOSWORTH CH IHarry J. Bosworth Co.1996-05-24EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816519021555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816519021555008165190215558165190215550816519021555

GMDN Terms#

Term, Definition table
TermDefinition
Dental pulp-capping materialA dental compound designed to cover an exposed or nearly-exposed dental pulp (e.g., due to deep cavities) to provide protection against external influences and to promote healing. This compound does not have dental cement or dental cavity liner intended uses. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830702846
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322591Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322614Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322973Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
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