FDA.reportPublic FDA data

E-Guide

Primary DI
42606832201330
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
42606832201330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4260683220133042606832201330

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 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

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