FDA.reportPublic FDA data

E-Guide

Primary DI
04260683220133
Brand
E-Guide
Company
Envisiontec GmbH
Model
RES-01-3012
Catalog number
RES-01-3012
Device description
E-Guide is a light-curing material for the additive manufacturing of individual dental surgical drill guides
Published
2020-08-11
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260683220133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260683220133042606832201334260683220133

GMDN Terms#

Term, Definition table
TermDefinition
Dental guided surgery reference plateA non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.

Storage And Handling#

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

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
08800016100686Dental Implants Accesseories-Single UseCowellmedi Co.,LtdNDP2026-08-03
08800016108774Dental Implants Accesseories-ReusableCowellmedi Co.,LtdNDP2026-07-28
08800076476271T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-27
D7702682153RIGHT ANGLE SCREWDRIVER FORSWEDEN & MARTINA SPANDP2026-07-27
D7702698973DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702698983DRILLSWEDEN & MARTINA SPANDP2026-07-27
D7702750843INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
D7702750853INTRAORAL SCANBODYSWEDEN & MARTINA SPANDP2026-07-27
03701045246374KONTACTBIOTECH DENTALNDP2026-07-24
03701045246381KontactBIOTECH DENTALNDP2026-07-24
08800076470569HS Cap SmallTruabutment Korea Co.,LtdNDP2026-07-21
08800076475830T-L Digital AnalogTruabutment Korea Co.,LtdNDP2026-07-21
08800076476042T-Marker KitTruabutment Korea Co.,LtdNDP2026-07-21
08800076476059T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476066T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476073T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476080T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476097T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476103T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476110T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476127T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476134T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476141T-MarkerTruabutment Korea Co.,LtdNDP2026-07-21
08800076476172T-Marker ScrewTruabutment Korea Co.,LtdNDP2026-07-21
08800076476219TruBite ScopeTruabutment Korea Co.,LtdNDP2026-07-21
08800076476226TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08800076476233TruBoltTruabutment Korea Co.,LtdNDP2026-07-21
08435673515131DYNAMIC ABUTMENT SOLUTIONSTALLADIUM ESPAÑA SLNDP2026-07-20
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14