FDA.reportPublic FDA data

Comfort Cap 10PK

Primary DI
D990CC10PK0
Brand
Comfort Cap 10PK
Company
SMART DENTURE CONVERSIONS, LLC
Model
CC10PK
Published
2025-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D990CC10PK0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8555500707contact@smartdentureconversions.com

Regulatory Flags#

DUNS number
010613514
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D990SADCK1PK0Single Arch Dam Conversion Kit 1PKSADCK1PK2025-06-30
D990AD0Access Drill 1PKAD2022-12-26
D990BHHDPS10PK0Prosthetic Screw 10PK, BioHorizonsBHHD-PS10PK2022-12-26
D990BHHDPSK0Premium Starter Kit, BioHorizonsBHHD-PSK2022-12-26
D990BHHDRK0Recharge Kit, BioHorizonsBHHD-RK2022-12-26
D990BHHDSFA10PKDK0Separable Fastener Assembly 10PK w Drill Kit, BioHorizonsBHHD-SFA10PKDK2022-12-26
D990BHHDSK0Starter Kit, BioHorizonsBHHD-SK2022-12-26
D990CM10PK0Coating Mandrel 10PKCM10PK2022-12-26
D990CM6PK0Coating Mandrel 6PKCM6PK2022-12-26
D990COD0Clean Out Drill 1PKCOD2022-12-26
D990DK0Drill Kit 1PKDK2022-12-26
D990KDIHCM10PK0Coating Mandrel 10 Pack, Paltop (IHEX)KDIH-CM10PK2022-12-26
D990KDIHCM6PK0Coating Mandrel 6PK, Paltop (IHex)KDIH-CM6PK2022-12-26
D990KDIHLA10PK0Lab Analog 10PK, Paltop (IHex)KDIH-LA10PK2022-12-26
D990KDIHLTD0Torque Driver 1PK, Paltop (IHex)KDIH-LTD2022-12-26
D990KDIHPS10PK0Prosthetic Screw 10PK, Paltop (IHex)KDIH-PS10PK2022-12-26
D990KDIHPSK0Premium Starter Kit, Paltop (IHex)KDIH-PSK2022-12-26
D990KDIHRK0Recharge Kit, Paltop (IHex)KDIH-RK2022-12-26
D990KDIHSFA10PKDK0Separable Fastener Assembly 10PK - Drill Kit Included, Paltop (IHex)KDIH-SFA10PKDK2022-12-26
D990KDIHSK0Starter Kit, Paltop (IHex)KDIH-SK2022-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8509ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851517ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851530ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11