FDA.reportPublic FDA data

Flexcera Smile Bleach

Primary DI
04260683220331
Brand
Flexcera Smile Bleach
Company
Envisiontec GmbH
Model
RES-01-3139
Catalog number
RES-01-3139
Device description
Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.
Published
2021-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELJTeeth, Artificial, Posterior With Metal Insert
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELJTeeth, Artificial, Posterior With Metal InsertDental1
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260683220331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260683220331042606832203314260683220331

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

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.com

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
04260683220423Flexcera™ Smile Ultra+ A3RES-01-3148RES-01-31482022-01-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B030Printer Resin Denture Tooth Temporary B3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B040Printer Resin Denture Tooth Temporary B4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405BLE0Printer Resin Denture Tooth Temporary Bleach (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C010Printer Resin Denture Tooth Temporary C1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C020Printer Resin Denture Tooth Temporary C2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C030Printer Resin Denture Tooth Temporary C3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C040Printer Resin Denture Tooth Temporary C4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D020Printer Resin Denture Tooth Temporary D2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D030Printer Resin Denture Tooth Temporary D3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D040Printer Resin Denture Tooth Temporary D4 (500g)ZIRKONZAHN SRLPZY2026-05-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCPZY2026-04-13
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00850070544740Crown HT - A1 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544757Crown HT - A2 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544788OnX Tough 2 - A1 - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544795OnX Tough 2 - Bleach - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544931Crown HT - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544948Crown HT - A2 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
08056865154466ACRY NATURE AFG 6 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155647ACRY NATURE AFG 6 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155654ACRY NATURE AFG 8 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155661ACRY NATURE AFG 8 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17