Reflect Implant System RCHA4504

GUDID 00817773025334

Reflect™ Certus 4.1 Healing Abutment 5D x 4H

INTEGRATED DENTAL SYSTEMS, LLC

Dental bone matrix implant, metallic Dental bone matrix implant, metallic Dental bone matrix implant, metallic Dental bone matrix implant, metallic
Primary Device ID00817773025334
NIH Device Record Key642f161b-8b8e-4e71-9edd-d7cbbb87ed18
Commercial Distribution StatusIn Commercial Distribution
Brand NameReflect Implant System
Version Model NumberRCHA4504
Catalog NumberRCHA4504
Company DUNS079439145
Company NameINTEGRATED DENTAL SYSTEMS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817773025334 [Primary]
GS100817773025334 [Primary]
GS100817773025334 [Primary]
GS100817773025334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form
DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Reflect Implant System]

00817773025334Reflect™ Certus 4.1 Healing Abutment 5D x 4H
00817773025297Reflect Aspire 3.5/4.0 Healing Abutment 4.0D x 2H
00817773025280Reflect Aspire 3.5/4.0 Healing Abutment 5.5D x 2H
00817773025273Reflect Aspire 3.5/4.0 Healing Abutment 4.5D x 4H
00817773025266Reflect Aspire 3.5/4.0 Healing Abutment 5.5D x 4H
00817773025259Reflect Aspire 3.5/4.0 Healing Abutment 6.5D x 4H
00817773025242Reflect Aspire 3.5/4.0 Healing Abutment 4.5D x 6H
00817773025235Reflect Aspire 3.5/4.0 Healing Abutment 5.5D x 6H
00817773025228Reflect Aspire 3.5/4.0 Healing Abutment 6.5D x 6H
00817773025211Reflect Aspire 4.5/5.0 Healing Abutment 5.5D x 2H
00817773025204Reflect Aspire 4.5/5.0 Healing Abutment 6.5D x 2H
00817773025198Reflect Aspire 4.5/5.0 Healing Abutment 5.5D x 4H
00817773025181Reflect Aspire 4.5/5.0 Healing Abutment 6.5D x 4H
00817773025174Reflect Aspire 4.5/5.0 Healing Abutment 5.5D x 6H
00817773025167Reflect Aspire 4.5/5.0 Healing Abutment 6.5D x 6H
00817773024153Reflect Rapid 5.0 x 15mm
00817773024108Reflect Rapid 4.3 x 15mm
00817773022159Reflect Certus 5.0 X 15
00817773022104Reflect Certus 4.1 X 15
00817773022098Reflect Certus 4.1 X 13
00817773022081Reflect Certus 4.1 X 11.5
00817773022074Reflect Certus 4.1 X 10
00817773022067Reflect Certus 4.1 X 8.5
00817773022050Reflect Certus 3.4 X 15
00817773022043Reflect Certus 3.4 X 13
00817773022036Reflect Certus 3.4x11.5
00817773022029Reflect Certus 3.4x10
00817773022012Reflect Certus 3.4x8.5
00817773021145Reflect Aspire 5.0x15
00817773021138Reflect Aspire 5.0x13
00817773021121Reflect Aspire 5.0x11
00817773021114Reflect Aspire 5.0x9
00817773021107Reflect Aspire 4.0x15
00817773021091Reflect Aspire 4.0x13
00817773021084Reflect Aspire 4.0x11
00817773021077Reflect Aspire 4.0x9
00817773021060Reflect Aspire 4.0x8
00817773021053Reflect Aspire 3.5x15
00817773021039Reflect Aspire 3.5x11
00817773021022Reflect Aspire 3.5x9
00817773021015Reflect Aspire 3.5x8
00817773025495Reflect Certus Open-Tray
00817773025488Reflect Certus 4.1 Healing
00817773025471Reflect Certus 4.1 Healing
00817773025464Reflect Certus Closed-Tray Tran 3.4 x 3.4D x 10H
00817773025457Reflect Certus Closed-Tray Tran 4.1 x 4.1D x 10H
00817773025440Reflect Certus Closed-Tray Tran 5.0 x 5.0D x 10H
00817773025433Reflect™ Certus 3.4 Healing Abutment Ø3.4 x 2H
00817773025426Reflect™ Certus 3.4 Healing Abutment Ø3.4 x 3H
00817773025419Reflect™ Certus 3.4 Healing Abutment Ø3.4 x 4H

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