← Product Code [NRQ](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NRQ) · K211872
# PiezoImplant System (K211872)
_Rex Implants, Inc. · NRQ · Oct 12, 2022 · Dental · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NRQ/K211872
## Device Facts
- **Applicant:** Rex Implants, Inc.
- **Product Code:** [NRQ](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NRQ.md)
- **Decision Date:** Oct 12, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3640
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic
## Indications for Use
The PiezoImplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The PiezoImplant System is intended for delayed loading.
## Device Story
The PiezoImplant System consists of wedge-shaped, blade-form endosseous dental implants, surgical instruments, and restorative components. Implants feature a resorbable blast media (RBM) surface and are available in 1.8mm and 2.9mm buccolingual thicknesses. The system is used by dental clinicians in clinical settings to provide a foundation for prosthetic restorations (crowns, bridges, dentures). Implants are placed via press-fit and osseointegration; prosthetic components (abutments, screws) are attached to the implants to support restorations. The device is intended for delayed loading. By providing a stable, osseointegrated anchor in narrow bone ridges, the system restores chewing function and oral aesthetics for patients. Clinicians use the system to address anatomical limitations where traditional root-form implants may be less suitable.
## Clinical Evidence
Two clinical studies were submitted. Study 1: Case series of 56 patients (111 implants); 79 implants met 12-month post-loading criteria. 88.6% success rate per ICOI Health Scale; mean bone loss -0.05 mm post-loading. Study 2: Prospective multicenter cohort of 44 patients (59 implants). 58/59 implants satisfactory at 1 year post-loading; mean marginal bone loss 0.20 mm between loading and 12 months post-loading. Both studies demonstrate clinical performance and osseointegration capability.
## Technological Characteristics
Materials: Titanium alloy (ASTM F136). Design: Wedge-shaped blade-form endosseous implants; 1.8mm/2.9mm buccolingual thickness; 9-15mm length. Surface: RBM blasted. Connection: Internal/external hex with screw attachment. Abutments: Healing, angled, straight, provisional, multi-unit. Sterilization: ISO 11137-1/-2 (sterile) or ISO 17665-1/-2 (non-sterile).
## Regulatory Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
## Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
*Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
## Predicate Devices
- Biomet 3i T3 (Biomet 3i™, [K133049](/device/K133049.md))
## Reference Devices
- Startanius™ NRI (Park Dental Research Corp., [K854749](/device/K854749.md))
- Zimmer Tapered Screw-Vent (Zimmer Dental Inc, [K061410](/device/K061410.md))
- Xive Dental Implant System (FRIADENT GmbH - [K032158](/device/K032158.md))
## Submission Summary (Full Text)
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Rex Implants, Inc. % Karen Warden President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K211872
Trade/Device Name: PiezoImplant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: NRO. NHA Dated: September 13, 2022 Received: September 14, 2022
Dear Karen Warden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K211872
#### Device Name
PiezoImplant System
Indications for Use (Describe)
The PiezoImplant System is intended for use in dental implant applications for oral rehabilitation of edentulous and partially dentate adult patients over the age of 21 in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The prosthetic components are connected to the implants by the corresponding abutments. The PiezoImplant System is intended for delayed loading.
| Type of Use ( Select one or both, as applicable ) |
|--------------------------------------------------------------------------------------------------------------------------------------|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) Summary
| Date: | 6 October 2022 | |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Rex Implants, Inc.
850 Michigan Avenue
Columbus, OH 43215
Phone 614.459.4922 | |
| Sponsor Contact: | Giuseppe Vercellotti, PhD, President | |
| 510(k) Contact: | Karen E. Warden, PhD
BackRoads Consulting Inc.
PO Box 566
Chesterland, OH 44026
Office: 440.729.8457 | |
| Trade Name: | Piezolmplant System | |
| Common Name: | Endosseous dental implants and dental abutments | |
| Device Classification | Class II | |
| Regulation Name,
Regulation, Device
Product Code: | Endosseous Dental Implant, 872.3640, NRQ
Endosseous Dental Implant Abutment, 872.3630, NHA | |
| Device Description: | The Piezolmplant System consists of endosseous dental implants, surgical
instruments and restorative components in a variety of dimensions to
accommodate differing patient anatomy. The Rex TL endosseous implants are
blade-form having a wedge shape and an endosseous resorbable blast media
(RBM) surface. The REX TL 1.8 implant series has a buccolingual thickness
of 1.8mm, a mesiodistal width of 5mm and an external hex connection
platform. The REX TL 2.9 implant series has a buccolingual thickness of
2.9mm, a mesiodistal width of 5mm and an internal hex connection platform.
The endosseous lengths for both implant series range from 9mm to 15mm and
all lengths are offered for both series. Cover screws provide protection to the
threads of the abutment connection during endosseous and gingival healing.
Retention screws fasten the implant and abutment. A variety of Piezolmplant
abutments are offered including Healing, Angled, Straight, Provisional
Cylinders and Multi-unit. Restorations can be screw and/or cement-retained to
the abutments. | |
| Indications for Use: | The Piezolmplant System is intended for use in dental implant applications for
oral rehabilitation of edentulous and partially dentate adult patients over the
age of 21 in the maxilla and mandible. Implant retained restorations may
consist of single crowns or bridges as well as complete or partial dentures.
The prosthetic components are connected to the implants by the
corresponding abutments. The Piezolmplant System is intended for delayed
loading. | |
| Materials: | The Piezolmplant System implants, abutments, cover screws and retention
screws are manufactured from titanium alloy (Ti-6AI-4V ELI) as described by
ASTM F136. | |
| Primary Predicate: | Biomet 3i T3 (Biomet 3i™, K133049) | |
| Reference devices: | Startanius™ NRI (Park Dental Research Corp., K854749).
Published clinical results for the following reference devices provided
comparative information to support substantial equivalence.
Zimmer Tapered Screw-Vent (Zimmer Dental Inc, K061410) and
Xive Dental Implant System (FRIADENT GmbH - K032158) | |
| | Subject Device | Primary Predicate |
| System: | Piezolmplant System | Biomet 3i |
| 510(k) Number: | K211872 | K133049 |
| | The Piezolmplant System is
intended for use in dental implant
applications for oral rehabilitation
of edentulous and partially dentate
adult patients over the age of 21 in
the maxilla and mandible. Implant
retained restorations may consist
of single crowns or bridges as well
as complete or partial dentures.
The prosthetic components are
connected to the implants by the
corresponding abutments. The
Piezolmplant System is intended
for delayed loading. | 3i T3® dental implants are
intended for surgical placement in
the upper or lower jaw to provide a
means for prosthetic attachment in
single tooth restorations and in
partially or fully edentulous spans
with multiple single teeth utilizing
delayed or immediate loading, or
as a terminal or intermediary
abutment for fixed or removable
bridgework, and to retain
overdentures.
3i T3® Dental Implants are
intended for immediate function on
single tooth and/or multiple tooth
applications when good primary
stability is achieved, with
appropriate occlusal loading, in
order to restore chewing function. |
| Comparison: | The subject device has the same intended use as the primary
predicate device except that the predicate device is additionally
intended for use in immediate loading situations. The subject device is
not intended for use in immediate loading situations. However, the
intended use for the subject device is encompassed by the intended
use for the predicate device therefore this difference does not affect
safety or effectiveness. | |
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## Indications for Use:
## Technological Characteristics:
| | Subject Device | Primary Predicate | Reference Device |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------|
| System: | Piezolmplant System | Biomet 3i | Startanius™ NRI |
| 510(k) Number: | K211872 | K133049 | K854749 |
| Material of
manufacture: | Titanium alloy (ASTM
F136) | CP Titanium (ASTM
F67) | Titanium alloy
(Ti6Al4V) |
| Design: | | | |
| Endosseous implant | Wedge shaped blade-
form | Root-form, Straight
and tapered | Blade-form |
| Method of stabilization | Press-fit +
Osseointegration | Threaded fixation | Press-fit +
Osseointegration |
| Buccolingual range | 1.8 & 2.9mm | Ø3.25 – 6mm | 1.02 to 3.3mm |
| Width | 5mm | | 6.05mm |
| Endosseous Lengths | 9-15 mm | 6.5 – 18mm | 8 – 14mm |
| Modified surface | Yes, RBM blasted
endosseous surface | Yes, apical surface
RBM blasted + dual
acid etched | Yes, surface is RBM
blasted and acid
etched |
| Connection to
abutment | Hex alignment
(internal and external),
screw attachment | Hex alignment, screw
attachment | Hex alignment, screw
attachment |
| | Subject Device | Primary Predicate | Reference Device |
| System: | PiezlImplant System | Biomet 3i | Startanius™ NRI |
| 510(k) Number: | K211872 | K133049 | K854749 |
| Abutments | | | |
| Healing | Healing Abutment TL
1.8 & 2.9 | EP® Healing Abutment
(One Piece) | Standard and Wide
Healing Abutment |
| Surface Treatment | Color Anodized | None | None |
| Emergence Profile Ø | 3.3, 4.5mm | 3.8 - 7.5mm | 4.25 - 5.3 mm |
| Collar Height | 1 - 4mm | 2 - 8mm | 2 - 5mm |
| Angulation | 0° | 0° | 0° |
| Material | ASTM F136 | CP titanium | |
| Angled | Angled Abutment TL
1.8 & 2.9 | Angled GingiHue®
Post | 25 Degree Angled
Cementable Abutment |
| Surface Treatment | None | Gold-colored titanium
nitride | None |
| Emergence Profile Ø | 5mm | 3.8 - 6mm | |
| Collar Height | 2mm | 2 - 4mm | |
| Angulation | 15°, 17° | 15° | 25° |
| Material | ASTM F136 | Titanium Alloy | Titanium |
| Straight | Straight Abutment TL
1.8 & 2.9 | Straight GingiHue®
Post | Hexed Cementable
Abutment |
| Surface Treatment | Color Anodized | Gold titanium nitride | None |
| Emergence Profile Ø | 5mm | 3.8 - 6mm | |
| Collar Height | 3mm…
---
**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NRQ/K211872](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NRQ/K211872)
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