FDA.report

Inclusive

Primary DI
D745701047COM01820
Brand
Inclusive
Company
Prismatik Dentalcraft, Inc
Model
70-1047-COM0182
Catalog number
70-1047-COM0182
Device description
Inclusive Laboratory Scanning Abutment compatible with: Biomet 3i Certain 6.0 mm
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D745701047COM01820PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(949)251-1269Marilyn.Pourazar@glidewelldental.com

Regulatory Flags

DUNS number
022761689
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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