FDA.reportPublic FDA data

Flexcera™ Smile Ultra+ A3

Primary DI
04260683220423
Brand
Flexcera™ Smile Ultra+ A3
Company
Envisiontec GmbH
Model
RES-01-3148
Catalog number
RES-01-3148
Device description
Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges.
Published
2022-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBGCrown And Bridge, Temporary, Resin
EBIResin, Denture, Relining, Repairing, Rebasing
ELMDenture, Plastic, Teeth
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2
EBIResin, Denture, Relining, Repairing, RebasingDental2
ELMDenture, Plastic, TeethDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260683220423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260683220423042606832204234260683220423

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridge resinA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Protect from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49204398750info@envisiontec.de

Regulatory Flags#

DUNS number
332025159
Device count
1
Premarket exempt
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
04260683220652SmileGuardRES-01-3194RES-01-31942022-08-19
04260683220041E-Guard BlueRES-01-3121RES-01-31212020-12-17
04260683220102E-GuardRES-01-3113RES-01-31132020-12-02
04260683220911Flexcera Base Ultra+ PinkRES-01-3500RES-01-35002023-09-13
04260683220928Flexcera™ Base Ultra+ Medium PinkRES-01-3501RES-01-35012023-09-13
04260683220935Flexcera™ Base Ultra+ Dark PinkRES-01-3502RES-01-35022023-09-13
04260683220942Flexcera Base Ultra+ Light PinkRES-01-3503RES-01-35032023-09-13
04260683220959Flexcera Base Ultra+ Dark MeharryRES-01-3504RES-01-35042023-09-13
04260683220836Flexcera™ Smile Ultra+ for Carbon® Printers BleachRES-01-3351RES-01-33512023-08-02
04260683220843Flexcera™ Smile Ultra+ for Carbon® Printers A1RES-01-3346RES-01-33462023-08-02
04260683220850Flexcera™ Smile Ultra+ for Carbon® Printers A2RES-01-3347RES-01-33472023-08-02
04260683220867Flexcera™ Smile Ultra+ for Carbon® Printers B1RES-01-3350RES-01-33502023-08-02
04260683220409Flexcera™ Smile Ultra+ A1RES-01-3146RES-01-31462022-01-21
04260683220416Flexcera™ Smile Ultra+ A2RES-01-3147RES-01-31472022-01-21
04260683220430Flexcera™ Smile Ultra+ A3.5RES-01-3149RES-01-31492022-01-21
04260683220447Flexcera™ Smile Ultra+ B1RES-01-3150RES-01-31502022-01-21
04260683220454Flexcera™ Smile Ultra+ BleachRES-01-3151RES-01-31512022-01-21
04260683220461Flexcera™ Smile Ultra+ A1 0.5kgRES-01-3182RES-01-31822022-01-21
04260683220478Flexcera™ Smile Ultra+ A2 0.5kgRES-01-3183RES-01-31832022-01-21
04260683220485Flexcera™ Smile Ultra+ A3 0.5kgRES-01-3184RES-01-31842022-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
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