FDA.reportPublic FDA data

IQ Dental

Primary DI
00816519021371
Brand
IQ Dental
Company
IQ DENTAL SUPPLY LLC
Model
NRGTCBB1
Device description
Temporary Crown & Bridge Materials Shade B1 w/10 tips
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K081810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081810000PULPDENT TEMPORARY CROWN AND BRIDGE MATERIALPulpdent Corporation2008-09-17EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816519021371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816519021371008165190213718165190213710816519021371

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge, temporaryA prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
830702846
Device count
1
Lot or batch
true
Manufacturing date on label
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
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761417FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761424FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761516FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761707FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761714FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761806FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761899FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761998FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201762186FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
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