FDA.reportPublic FDA data

Inclusive

Primary DI
D745701066MNP00081
Brand
Inclusive
Company
Prismatik Dentalcraft, Inc
Model
70-1066-MNP0008
Catalog number
70-1066-MNP0008
Device description
"Inclusive Mini Implant Prosthetic O-Rings 3/16"" x 1/16"" (10-pack)"
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D745701066MNP00081PrimaryHIBCC0
D745701066MNP00080Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(949)440-2629Shelly.Harris@glidewelldental.com

Regulatory Flags#

DUNS number
022761689
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701204GLG00011Glidewell™70-1204-GLG000170-1204-GLG00012026-04-15
D745701204GLG00021Glidewell™70-1204-GLG000270-1204-GLG00022026-04-15
D745701204GLG00031Glidewell™70-1204-GLG000370-1204-GLG00032026-04-15
D745701204GLG00041Glidewell™70-1204-GLG000470-1204-GLG00042026-04-15
D745701204GLG00051Glidewell™70-1204-GLG000570-1204-GLG00052026-04-15
D745701190PRA00650Glidewell HT™70-1190-PRA006570-1190-PRA00652025-03-10
D745701190PRA00660Glidewell HT™70-1190-PRA006670-1190-PRA00662025-03-10
D745701190PRA00670Glidewell HT™70-1190-PRA006770-1190-PRA00672025-03-10
D745701190PRA00680Glidewell HT™70-1190-PRA006870-1190-PRA00682025-03-10
D745701190PRA00690Glidewell HT™70-1190-PRA006970-1190-PRA00692025-03-10
D745701190PRA00010Glidewell HT™70-1190-PRA000170-1190-PRA00012024-03-21
D745701190PRA00020Glidewell HT™70-1190-PRA000270-1190-PRA00022024-03-21
D745701190PRA00030Glidewell HT™70-1190-PRA000370-1190-PRA00032024-03-21
D745701190PRA00040Glidewell HT™70-1190-PRA000470-1190-PRA00042024-03-21
D745701190PRA00050Glidewell HT™70-1190-PRA000570-1190-PRA00052024-03-21
D745701190PRA00060Glidewell HT™70-1190-PRA000670-1190-PRA00062024-03-21
D745701190PRA00070Glidewell HT™70-1190-PRA000770-1190-PRA00072024-03-21
D745701190PRA00080Glidewell HT™70-1190-PRA000870-1190-PRA00082024-03-21
D745701190PRA00090Glidewell HT™70-1190-PRA000970-1190-PRA00092024-03-21
D745701190PRA00100Glidewell HT™70-1190-PRA001070-1190-PRA00102024-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03