FDA.reportPublic FDA data

Dentemp

Primary DI
00010705400852
Brand
Dentemp
Company
MAJESTIC DRUG CO. INC.
Model
1
Device description
Dentemp is a 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
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964773000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964773000DENTEMP ONE STEPMajestic Drug Co., Inc.1997-02-21EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20010705400856PackageGS116In Commercial Distribution
70010705400851PackageGS16In Commercial Distribution
00010705400852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2001070540085620010705400856
7001070540085170010705400851
00010705400852000107054008520107054008520010705400852

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
00010705400814DenTemp Custom12016-07-27
00010705400883Refilit12016-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
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
07615208300833Multilink Automix / Primer A+BIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2023-04-06
07615208315301Telio DesensitizerIVOCLAR VIVADENT AKTIENGESELLSCHAFTEMA2022-09-29
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10386040008792GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008808GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008815GC Fuji II LC®Gc America Inc.EMA2022-07-13
10386040008822GC Fuji II LC®Gc America Inc.EMA2022-07-13