FDA.report

Inclusive

Primary DI
D745701047COM01400
Brand
Inclusive
Company
Prismatik Dentalcraft, Inc
Model
70-1047-COM0140
Catalog number
70-1047-COM0140
Device description
Inclusive Multi-Unit Abutment 5 mmH compatible with: Biomet 3i Certain 4.1 mm
Published
2015-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D745701047COM01400PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

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
false
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

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D745701161COM00020Inclusive®70-1161-COM000270-1161-COM00022025-12-01
D745701161COM00040Inclusive®70-1161-COM000470-1161-COM00042025-12-01
D745701161COM00050Inclusive®70-1161-COM000570-1161-COM00052025-12-01
D745701161COM00060Inclusive®70-1161-COM000670-1161-COM00062025-12-01
D745701161COM00080Inclusive®70-1161-COM000870-1161-COM00082025-12-01
D745701161COM00090Inclusive®70-1161-COM000970-1161-COM00092025-12-01
D745701161COM00100Inclusive®70-1161-COM001070-1161-COM00102025-12-01
D745701161COM00120Inclusive®70-1161-COM001270-1161-COM00122025-12-01
D745701161COM00130Inclusive®70-1161-COM001370-1161-COM00132025-12-01
D745701161COM00140Inclusive®70-1161-COM001470-1161-COM00142025-12-01
D745701161COM00160Inclusive®70-1161-COM001670-1161-COM00162025-12-01
D745701161COM00170Inclusive®70-1161-COM001770-1161-COM00172025-12-01
D745701161COM00180Inclusive®70-1161-COM001870-1161-COM00182025-12-01
D745701161COM00200Inclusive®70-1161-COM002070-1161-COM00202025-12-01
D745701161COM00210Inclusive®70-1161-COM002170-1161-COM00212025-12-01
D745701161COM00220Inclusive®70-1161-COM002270-1161-COM00222025-12-01

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