FDA.reportPublic FDA data

PiezoImplant System

Primary DI
D894T2130
Brand
PiezoImplant System
Company
Rex Implants, Inc.
Model
REX TL 2.9 H13
Catalog number
T2-13
Device description
REX TL 2.9 H13 Assembly (Implant, Retention Screw TL 2.9, Transfer / Straight Abutment TL 2.9) packaged with Cover Screw TL 2.9
Published
2022-12-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRQBlade-Form Endosseous Dental Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRQBlade-Form Endosseous Dental ImplantDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211872000PiezoImplant SystemRex Implants, Inc.2022-10-12NRQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D894T2130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height13Millimeter
Width5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
6146538429info@reximplants.com

Regulatory Flags#

DUNS number
080746478
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D894B2094C0PiezoImplant SystemREX BL 2.9 x 4 H9B2-094C2022-12-24
D894B2095C0PiezoImplant SystemREX BL 2.9 x 5 H9B2-095C2022-12-24
D894B2114C0PiezoImplant SystemREX BL 2.9 x 4 H11B2-114C2022-12-24
D894B2115C0PiezoImplant SystemREX BL 2.9 x 5 H11B2-115C2022-12-24
D894B2134C0PiezoImplant SystemREX BL 2.9 x 4 H13B2-134C2022-12-24
D894B2135C0PiezoImplant SystemREX BL 2.9 x 5 H13B2-135C2022-12-24
D894B2154C0PiezoImplant SystemREX BL 2.9 x 4 H15B2-154C2022-12-24
D894B2155C0PiezoImplant SystemREX BL 2.9 x 5 H15B2-155C2022-12-24
D894R4040PiezoImplant SystemRetention Screw BL 2.9R4-042022-12-30
D894R4050PiezoImplant SystemStraight Abutment BL 2.9 H1R4-052022-12-30
D894R4060PiezoImplant SystemStraight Abutment BL 2.9 H2R4-062022-12-30
D894R4070PiezoImplant SystemStraight Abutment BL 2.9 H3R4-072022-12-30
D894R4080PiezoImplant SystemCover Screw BL 2.9R4-082022-12-30
D894R4090PiezoImplant SystemImpression Pin L BL 2.9R4-092022-12-30
D894R4100PiezoImplant SystemImpression Pin S BL 2.9R4-102022-12-30
D894R4120PiezoImplant SystemLab Analog BL 2.9R4-122022-12-30
D894R4130PiezoImplant SystemHealing Abutment BL 2.9 H1R4-132022-12-30
D894R4140PiezoImplant SystemHealing Abutment BL 2.9 H2R4-142022-12-30
D894R4150PiezoImplant SystemHealing Abutment BL 2.9 H3R4-152022-12-30
D894R4160PiezoImplant SystemHealing Abutment BL 2.9 H4R4-162022-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D894T1090PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T109R0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T1110PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T111R0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T1130PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T113R0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T1150PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T115R0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T2090PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T209R0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T2110PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T211R0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T213R0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T2150PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894T215R0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894B2094C0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894B2095C0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894B2114C0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894B2115C0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894B2134C0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894B2135C0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894B2154C0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24
D894B2155C0PiezoImplant SystemRex Implants, Inc.NRQ2022-12-24