FDA.report

Inclusive

Primary DI
D745701047COM01530
Brand
Inclusive
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1047-COM0153
Catalog number
70-1047-COM0153
Device description
Inclusive Prosthetic Screw .048" Hex
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D745701047COM01530PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

Device Sizes

TypeValueUnit
Height3.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
021228671
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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