FDA.reportPublic FDA data

PiezoImplant System

Primary DI
D894R4350
Brand
PiezoImplant System
Company
Rex Implants, Inc.
Model
MUA Temporary Coping BL 2.9
Catalog number
R4-35
Published
2022-12-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D894R4350PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6146538429info@reximplants.com

Regulatory Flags#

DUNS number
080746478
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14