FDA.reportPublic FDA data

Reflect Implant System

Primary DI
00817773025488
Brand
Reflect Implant System
Company
INTEGRATED DENTAL SYSTEMS, LLC
Model
RCHA4504C
Catalog number
RCHA4504C
Device description
Reflect Certus 4.1 Healing
Published
2020-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180924000Reflect Implant SystemIds - Integrated Dental Systems2019-03-29DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817773025488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817773025488008177730254888177730254880817773025488

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, metallicA sterile non-bioabsorbable device made of metal and/or metal oxide [e.g., titanium (Ti)] implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is typically used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically available as porous granules.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-277-5662ids@idsimplants.com

Regulatory Flags#

DUNS number
079439145
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817773026201Reflect Implant SystemRCHA46042020-09-10
00817773026218Reflect Implant SystemRCHA55642020-09-10
00817773022111Reflect Implant SystemRC5085CRC5085C2020-05-14
00817773022128Reflect Implant SystemRC5010CRC5010C2020-05-14
00817773022135Reflect Implant SystemRC5011CRC5011C2020-05-14
00817773022142Reflect Implant SystemRC5013CRC5013C2020-05-14
00817773023019Reflect Implant SystemRR3508CRR3508C2020-05-14
00817773023026Reflect Implant SystemRR3510CRR3510C2020-05-14
00817773023033Reflect Implant SystemRR3511CRR3511C2020-05-14
00817773023040Reflect Implant SystemRR3513CRR3513C2020-05-14
00817773023057Reflect Implant SystemRR3516CRR3516C2020-05-14
00817773023064Reflect Implant SystemRR4308CRR4308C2020-05-14
00817773023071Reflect Implant SystemRR4310CRR4310C2020-05-14
00817773023088Reflect Implant SystemRR4311CRR4311C2020-05-14
00817773023095Reflect Implant SystemRR4313CRR4313C2020-05-14
00817773023101Reflect Implant SystemRR4316CRR4316C2020-05-14
00817773023118Reflect Implant SystemRR5008CRR5008C2020-05-14
00817773023125Reflect Implant SystemRR5010CRR5010C2020-05-14
00817773023132Reflect Implant SystemRR5011CRR5011C2020-05-14
00817773023149Reflect Implant SystemRR5013CRR5013C2020-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970154S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970161S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970178S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970185S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970192S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970208S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970222S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970239S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970246S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970253S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970260S-PlantIDIS CO.,LTDDZE2026-10-20
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14