FDA.reportPublic FDA data

Inclusive

Primary DI
D745701135CAM00640
Brand
Inclusive
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1135-CAM0064
Catalog number
70-1135-CAM0064
Device description
Inclusive Guide Pin (5-pack) compatible with: Camlog Screw-Line 3.3/3.8/4.3 mm
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
D745701135CAM00641PrimaryHIBCC0
D745701135CAM00640Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screw analog, reusableA device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7256xx@xx.xx

Regulatory Flags#

DUNS number
021228671
Device count
5
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
false
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
D745701047COM00580Inclusive70-1047-COM005870-1047-COM00582015-10-24
D745701155BXA00010BruxZir70-1155-BXA000170-1155-BXA00012016-09-23
D745701155BXA00030BruxZir70-1155-BXA000370-1155-BXA00032016-09-23
D745701155BXA00040BruxZir70-1155-BXA000470-1155-BXA00042016-09-23
D745701155BXA00050BruxZir70-1155-BXA000570-1155-BXA00052016-09-23
D745701155BXA00060BruxZir70-1155-BXA000670-1155-BXA00062016-09-23
D745701155BXA00070BruxZir70-1155-BXA000770-1155-BXA00072016-09-23
D745701155BXA00080BruxZir70-1155-BXA000870-1155-BXA00082016-09-23
D745701155BXA00090BruxZir70-1155-BXA000970-1155-BXA00092016-09-23
D745701155BXA00100BruxZir70-1155-BXA001070-1155-BXA00102016-09-23
D745701155BXA00110BruxZir70-1155-BXA001170-1155-BXA00112016-09-23
D745701155BXA00120BruxZir70-1155-BXA001270-1155-BXA00122016-09-23
D745701155BXA00140BruxZir70-1155-BXA001470-1155-BXA00142016-09-23
D745701155BXA00150BruxZir70-1155-BXA001570-1155-BXA00152016-09-23
D745701155BXA00160BruxZir70-1155-BXA001670-1155-BXA00162016-09-23
D745701155BXA00170BruxZir70-1155-BXA001770-1155-BXA00172016-09-23
D745701155BXA00190BruxZir70-1155-BXA001970-1155-BXA00192016-09-23
D745701155BXA00210BruxZir70-1155-BXA002170-1155-BXA00212016-09-23
D745701155BXA00220BruxZir70-1155-BXA002270-1155-BXA00222016-09-23
D745701155BXA00240BruxZir70-1155-BXA002470-1155-BXA00242016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013239MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013619MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013769MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013829MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA019019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028129MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028139MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028209MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028219MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08