FDA.report

Esthet-X®flow Liquid Micro Hybrid

Primary DI
D0026480221
Brand
Esthet-X®flow Liquid Micro Hybrid
Company
DENTSPLY INTERNATIONAL INC.
Model
648022
Catalog number
648022
Device description
Esthet-X®flow Liquid Micro Hybrid, A3, Syringe Refill Package
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EMACEMENT, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D0026480221PrimaryHIBCC0
D0026480220Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). 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

TypeValueUnit
Device Size Text, specify0
Weight1.3Gram

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags

DUNS number
083235549
Device count
2
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21
D0013010321Ceramco® 3Powder Opaque Modifier Sienna3010322016-09-21
D0013010361Ceramco® 3Powder Opaque Modifier Pink3010362016-09-21
D0013010371Ceramco® 3Powder Opaque Modifier Ochre3010372016-09-21
D0013010481Ceramco® 3Paste Opaque A3.53010482016-09-21
D0013010591Ceramco® 3Paste Opaque C23010592016-09-21
D0013010701Ceramco® 3Paste Opaque Modifiers White3010702016-09-21
D0013011031Ceramco® 3Opaceous Dentin i13011032016-09-21
D0013011071Ceramco® 3Opaceous Dentin A3.53011072016-09-21
D0013011101Ceramco® 3Opaceous Dentin i63011102016-09-21
D0013011181Ceramco® 3Opaceous Dentin C23011182016-09-21
D0013011221Ceramco® 3Opaceous Dentin D33011222016-09-21
D0013011501Ceramco® 3Dentin C43011502016-09-21
D0013011611Ceramco® 3Dentin Modifier A3.53011612016-09-21
D0013011671Ceramco® 3Dentin Modifier Blue3011672016-09-21
D0013012001Ceramco® 3Natural Enamel White3012002016-09-21
D0013012011Ceramco® 3Natural Enamel Extra Light3012012016-09-21
D0013013221Ceramco® 3Overglaze3013222016-09-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815967029472RodinPac-Dent, Inc.EMA2026-03-23
00815967029656RodinPac-Dent, Inc.EMA2026-03-23
00815967029663RodinPac-Dent, Inc.EMA2026-03-23
00815967029670RodinPac-Dent, Inc.EMA2026-03-23
00815967029687RodinPac-Dent, Inc.EMA2026-03-23
00815967029694RodinPac-Dent, Inc.EMA2026-03-23
00815967029700RodinPac-Dent, Inc.EMA2026-03-23
00815967029717RodinPac-Dent, Inc.EMA2026-03-23
00815967029724RodinPac-Dent, Inc.EMA2026-03-23
07290115050400High-Q-Bond SEB.J.M. LABORATORIES LTDEMA2026-03-20
00817169021438UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00817169021445UPTEMP By 3D DENTAL3D DENTAL DESIGNS AND DEVELOPMENT, LLCEMA2026-03-05
00840479201566GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201573GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201580GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201597GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
00840479201603GLASSLOKRELIANCE ORTHODONTIC PRODUCTS INCEMA2026-03-05
09336472005450RIVA CEM AUTOMIXSDI LIMITEDEMA2026-02-16
09336472020965RIVA CEM AUTOMIXSDI LIMITEDEMA2026-02-16
09336472032203RIVA CEMSDI LIMITEDEMA2026-02-16
04560227803397iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803403iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803410iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803427iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803434iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803441iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803458iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803465iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803472iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09
04560227803557iCEM Universal PlusSUN MEDICAL CO.,LTD.EMA2026-02-09