0817773021046 RS3513C

GUDID 00817773021046

Reflect Aspire 3.5x13

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 ID00817773021046
NIH Device Record Keya3c881b7-86cc-4ed4-a276-24e971d9111f
Commercial Distribution StatusIn Commercial Distribution
Brand Name0817773021046
Version Model NumberRS3513C
Catalog NumberRS3513C
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

Customer Support Contacts

Phone866-277-5662
Emailids@idsimplants.com
Phone866-277-5662
Emailids@idsimplants.com
Phone866-277-5662
Emailids@idsimplants.com
Phone866-277-5662
Emailids@idsimplants.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817773021046 [Primary]
GS100817773021046 [Primary]
GS100817773021046 [Primary]
GS100817773021046 [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

Devices Manufactured by INTEGRATED DENTAL SYSTEMS, LLC

00817773022111 - Reflect Implant System2020-05-22 Reflect Certus 5.0 X 8.5
00817773022128 - Reflect Implant System2020-05-22 Reflect Certus 5.0 X 10
00817773022135 - Reflect Implant System2020-05-22 Reflect Certus 5.0 X 11.5
00817773022142 - Reflect Implant System2020-05-22 Reflect Certus 5.0 X 13
00817773023019 - Reflect Implant System2020-05-22 Reflect Recover 3.5mm X 08mmL
00817773023026 - Reflect Implant System2020-05-22 Reflect Recover 3.5mm X 10mmL
00817773023033 - Reflect Implant System2020-05-22 Reflect Recover 3.5mm X 11.5mmL
00817773023040 - Reflect Implant System2020-05-22 Reflect Recover 3.5mm X 13mmL

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