PiezoImplant System

Primary DI
D894R4140
Brand
PiezoImplant System
Company
Rex Implants, Inc.
Model
Healing Abutment BL 2.9 H2
Catalog number
R4-14
Device description
Healing Abutment BL 2.9 H2
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

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
D894R4140PrimaryHIBCC0

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
Height2Millimeter
Outer Diameter2.6Millimeter

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
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
D894R4150PiezoImplant SystemHealing Abutment BL 2.9 H3R4-152022-12-30
D894R4160PiezoImplant SystemHealing Abutment BL 2.9 H4R4-162022-12-30
D894R4170PiezoImplant SystemHealing Abutment BL 2.9 H6R4-172022-12-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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