FDA.reportPublic FDA data

DenTemp Custom

Primary DI
00010705400814
Brand
DenTemp Custom
Company
MAJESTIC DRUG CO. INC.
Model
1
Device description
Dentemp Custom is a Zinc Oxide / Eugenol temporary dental cement for re-cementing loose caps or crowns and replacing lost fillings
Published
2016-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMBZinc Oxide Eugenol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMBZinc Oxide EugenolDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K821581000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821581000DEN TEMPMajestic Drug Co., Inc.1982-06-14EMB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30010705400815PackageGS124In Commercial Distribution
70010705400813PackageGS16In Commercial Distribution
00010705400814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3001070540081530010705400815
7001070540081370010705400813
00010705400814000107054008140107054008140010705400814

GMDN Terms#

Term, Definition table
TermDefinition
Home-use dental cementA non-sterile substance intended to be used as a dental cement/restorative material by a layperson in the home for immediate and temporary replacement of a lost filling or cementation of a dental crown, and to relieve pain, until a dental professional is accessed. It may be either a multicomponent material intended to be pre-mixed before application or a single-component paste; it is intended to be applied directly to the tooth and harden in situ. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
(800) 238-0220custserv@majesticdrug.com

Regulatory Flags#

DUNS number
001496777
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00010705400913Repair-It12016-07-27
20010705400917Repair-It12016-07-27
00010705400968Reline-It12016-07-27
00010705400456SenzAway12016-07-27
00010705400708Recapit12016-07-27
00010705400852Dentemp12016-07-27
00010705400883Refilit12016-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806383591690DIACEM TEMPNEDiaDent Group InternationalEMB2026-05-13
08806383591706DIACEM TEMPNEDiaDent Group InternationalEMB2026-05-13
00817169021421Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMB2026-03-11
D161280140AxioIRM 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
D161280150AxioIRM 75g powder 40ml liquidAxiodent Inc.EMB2024-09-29
D161280160AxioIRM XS 38g powder 14ml liquidAxiodent Inc.EMB2024-09-29
D161280170AxioZi-Temp 15g powder 10ml liquidAxiodent Inc.EMB2024-09-29
07898561542205MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542212Fill Canal Liquid (10 mL) 7898561542212 Maquira MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542229MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542236MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561542250MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546678MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
07898561546685MaquiraMaquira Industria de Produtos Odontologicos S/AEMB2024-08-07
00816526020220MASTER-DENTDENTONICS INCEMB2023-10-31
00816526020237MASTER-DENTDENTONICS INCEMB2023-10-31
05021752001065Alganol Powder 90gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-09-11
15060988910045JJ CAREJack Jack LLCEMB2023-07-15
05021752000723Eugenol B.P. Liquid 150mlASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
05021752000761Zinc Oxide B.P. Powder 150gASSOCIATED DENTAL PRODUCTS LIMITEDEMB2023-07-06
10852253006240Power Temp Cartridge KitJ. MORITA U.S.A., INCEMB2023-06-07
10852253006257Power Temp Mini Syringe KitJ. MORITA U.S.A., INCEMB2023-06-07
D95600ZOERF0Zoer ReinforcedD.S.I DENTAL SOLUTIONS LTDEMB2023-02-15
D9560ZOERQS0Zoer QuickD.S.I DENTAL SOLUTIONS LTDEMB2023-02-15
D9673001510ZinconolPREVEST DENPRO LIMITEDEMB2023-01-03
D967300160ZitempPREVEST DENPRO LIMITEDEMB2023-01-03
D967300150ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D96730015A09ZinconolPREVEST DENPRO LIMITEDEMB2022-12-19
D9673001600ZitempPREVEST DENPRO LIMITEDEMB2022-12-19
H66811475771Keystone IndustriesKeystone IndustriesEMB2022-11-30