FDA.reportPublic FDA data

Enamel Plus Temp ®

Primary DI
EMICTEMP1NOF1
Brand
Enamel Plus Temp ®
Company
MICERIUM SPA
Model
TEMP1N-OF
Catalog number
TEMP1N-OF
Device description
ENAMEL PLUS TEMP INTRODUCTORY KIT- 1 TEMP1-CLEAR; TEMP CLEAR 10g- 1 TEMP1-DOD; TEMP DOD 10g- 1 TEMP1-DOL; TEMP DOL 10g- 1 TEMP1-GREY; TEMP GREY 10g- 1 TEMP1-MO; TEMP MO (orange) 10g- 1 TEMP1-MY; TEMP MY (yellow) 10g- 1 TEMP1-PINK; TEMP PINK 10g- 1 TEMP1-UD0; TEMP UD0 10g- 1 TEMP1-UD1; TEMP UD1 10g- 1 TEMP1-UD5; TEMP UD5 10g- 1 TEMP1-UE1; TEMP UE1 10g- 1 TEMP1-UE3; TEMP UE3 10g- 1 TEMP1-WHITE; TEMP WHITE 10g- 1 TEMPL Self Curing 100 ml Liquid- 1 TEMPLC ENAMEL plus TEMP LIQ. FOTOP. 10ml - 1 TEMP50BLUE, BLUE 50G POWDER- 1 TEMP50UD2, UD2 50g POWDER- 1 TEMP50UD3, UD3 50g POWDER- 1 TEMP50UD3,5 UD3.5 50g POWDER- 1 TEMP50UD4, UD4 50g POWDER- 1 TEMP50UE2, UE2 50g POWDER
Published
2021-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K103474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103474000ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)Micerium S.P.A.2011-02-07EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMICTEMP1NOF1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental acrylic resinA non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight540Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature3 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436661136
Device count
1
Kit
true
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
EMICCOSZ251Ena Etch ®COSZ25COSZ252025-12-18
EMICESA01Ena ShinyESA0ESA02025-11-07
EMICESB01Ena ShinyESB0ESB02025-11-07
EMICCOS1010Ena Etch ®COS101COS1012018-11-16
EMICCOS101B0Ena Etch ®COS101BCOS101B2018-11-16
EMICCOSM1011Ena Etch ®COSM101COSM1012018-11-21
EMICCOSM101A1Ena Etch ®COSM101ACOSM101A2018-11-21
EMICCOSM101B1Ena Etch ®COSM101BCOSM101B2018-11-16
EMICCOSZ1001Ena Seal ®COSZ100COSZ1002018-11-21
EMICESG71Ena ShinyESG7ESG72021-02-12
EMICESG11Ena ShinyES+GES+G2024-08-06
EMICESYG0Ena ShinyES-Y+GES-Y+G2023-06-09
EMICESKIT01Ena ShinyESKITESKIT2023-06-08
EMICESA0Ena ShinyESAESA2021-02-12
EMICESA1Ena ShinyESAESA2021-02-12
EMICESB0Ena ShinyESBESB2021-02-12
EMICESB1Ena ShinyESBESB2021-02-12
EMICESC0Ena ShinyESCESC2021-02-12
EMICESC1Ena ShinyESCESC2021-02-12
EMICESC40Ena ShinyESC4ESC42021-02-12

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Primary DI, Brand, Company table
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