FDA.report

Inclusive

Primary DI
D745701072PRC00550
Brand
Inclusive
Company
Prismatik Dentalcraft, Inc
Model
70-1072-PRC0055
Catalog number
70-1072-PRC0055
Device description
Inclusive Tapered Implant Analog 3.0 mmP
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
true

Related Records

Contact Domains

Product Codes

CodeName
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D745701072PRC00550PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Device Sizes

TypeValueUnit
Height11Millimeter

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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D745701161COM00060Inclusive®70-1161-COM000670-1161-COM00062025-12-01
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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
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