K Number
K233316
Device Name
DESS Dental Smart Solutions
Manufacturer
Date Cleared
2024-01-05

(98 days)

Product Code
Regulation Number
872.3630
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
Device Description
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile. The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.
More Information

No
The submission describes a change in sterilization status for existing dental abutments and does not mention any AI or ML capabilities.

Yes.

The device is intended to be used in conjunction with endosseous dental implants to provide support for prosthetic restorations, directly interacting with the body to achieve a medical purpose.

No

The device consists of abutments and abutment screws used for prosthetic restorations on dental implants. It is a support device, not one that diagnoses a condition.

No

The device description clearly states the components are physical abutments and screws, which are hardware. The submission focuses on a change in sterilization status for these physical components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for providing support for prosthetic restorations in conjunction with dental implants. This is a mechanical function within the body, not a diagnostic test performed on samples outside the body.
  • Device Description: The description focuses on the physical components (abutments and screws) and their sterilization status. It does not mention any reagents, assays, or methods for analyzing biological samples.
  • Lack of IVD Keywords: There are no mentions of terms typically associated with IVDs such as "in vitro," "diagnostic," "assay," "reagent," "sample," "analyte," etc.
  • Performance Studies: The performance studies described relate to physical properties (MR compatibility, sterilization, biocompatibility, compatibility with implants), not diagnostic accuracy or performance metrics like sensitivity or specificity.

IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device is a physical component used in dental surgery.

N/A

Intended Use / Indications for Use

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.

The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws. A summary of the subject components is provided in the following table.

OEM Implant LinesHealing AbutmentsTemporary AbutmentsMunti-Unit Abutments, 0°Munti-Unit Abutments, 17° and 30°Screws
Ankylos C/XXXX
Astra Tech EVXXXXX
Astra Tech OsseoSpeed™XXXXX
BioHorizons InternalXX
Biomet 3i Certain®XXX
Biomet 3i OSSEOTITE®XXXX
CamlogXXX
Dentium SuperLineX
FRIADENT XiVE®XXX
Neodent Grand MorseXX
NobelActive®XXXXX
NobelReplace®XXXX
Nobel Brånemark System®XXXX
Osstem TSXX
Hiossen TSXX
Straumann BLXXXX
Straumann® Bone LevelXXXXX
Straumann® Tissue LevelXXXX
Zimmer Screw Vent®XXX
Tapered Screw-Vent®XXX
TSX™ Implant SystemXXX

Healing Abutments are compatible with the OEM implant lines as listed in this summary, and as protectors (healing attachments) for use with Straumann Converter Abutment for Straumann Tissue Level implants) and for DESS Multi-Unit Abutments. The Healing Abutments are provided in a range of gingival heights from 1 mm to 6.5 mm, and in a range of coronal (maximum) diameters of 3.5 mm to 7 mm.

Temporary Abutments are compatible with the OEM implant lines as listed in this summary and are available for single-unit and multiple-unit restorations. Temporary Abutments are provided in a range of gingival heights from 0.35 mm to 2.5 mm, and in a range of prosthetic platform diameters from 4.5 mm to 6.8 mm.

Multi-Unit Abutments are compatible with the OEM implant lines as listed in this summary in straight (00) and angled (17° and 30°) designs. Multi-Unit are provided in gingival heights from 1 mm to 6 mm for the straight (0°) designs, 2.5 mm to 4.5 mm for angled 17º designs, and 3.5 mm for the angled 30º designs.

Abutment screws are compatible with the OEM implant lines as listed in this summary. There are no changes to the design of the screws cleared previously in K170588. K212628. K191986, and K222288.

The subject device abutments and abutment screws have the same OEM implant compatibilities as the identical screws cleared in K170588, K212628, K191986, and K222288.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary or mandibular arch (dental implants)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical data submitted or referenced to demonstrate substantial equivalence included:

  • non-clinical analysis was performed to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque;
  • referenced from K212538 was gamma irradiation validation to a sterility assurance level of 10-6 by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 5, 2024

Terrats Medical SL % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real. Suite 400 San Diego, California 92130

Re: K233316

Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 2, 2024 Received: January 2, 2024

Dear Kevin Thomas:

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 (the 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 available 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.

1

2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

2

3

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 -S

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 Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known)

K233316

Device Name

DESS Dental Smart Solutions

Indications for Use (Describe)

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

Compatible Implant SystemImplant Body Diameter, mmImplant Platform Name
Ankylos C/X3.5, 4.5, 5.52.52
3.03.0
3.63.6
Astra Tech EV4.24.2
4.84.8
5.45.4
Astra Tech OsseoSpeed™3.5, 4.03.5/4.0
4.5, 5.04.5/5.0
BioHorizons Internal3.8, 4.63.5
4.6, 5.84.5
5.85.7
Biomet 3i Certain®3.253.4
4.04.1
5.05.0
Biomet 3i OSSEOTITE®3.253.4
3.75, 4.04.1
5.05.0
Camlog3.83.8
4.34.3
Dentium SuperLine3.6, 4.0, 4.5, 5.0, 6.0, 7.03.3
FRIADENT XiVE®3.43.4
3.83.8
4.54.5
Neodent Grand Morse3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0Grand Morse (GM)
NobelActive®3.5NP
NobelReplace Conical
NobelParallel Conical4.3, 5.0RP
NobelReplace®3.5NP
4.3RP
5.0WP
Nobel Brånemark System®3.3NP
3.75, 4.0RP
5.0WP
Osstem TS3.5Mini
Hiossen TS4.0, 4.5, 5.0, 6.0, 7.0Regular
Straumann BLX3.5, 3.75, 4.0, 4.5RB
5.0, 5.5, 6.5WB
Straumann® Bone Level3.3NC
4.1, 4.8RC
Straumann® Tissue Level3.3, 4.1, 4.8RN
4.8WN
Zimmer Screw Vent®3.3, 3.7, 4.13.5
4.74.5
Tapered Screw-Vent®6.05.7
TSXTM Implant System3.7, 4.1, 4.73.5
5.4, 6.04.5

Compatible Implant Systems

4

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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5

510(k) Summary K233316 Terrats Medical SL DESS Dental Smart Solutions January 2, 2024

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Terrats Medical SL
Carrer Mogoda, 75-99
Barberà del Vallès 08210
Barcelona, Spain |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | +34 935 646 006 |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone +1 858-792-1235
Fax +1 858-792-1236
Email kthomas@paxmed.com
flarson@paxmed.com |

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary NameDESS Dental Smart Solutions
Common NameDental implant abutment
Regulation Number21 CFR 872.3630
Regulation NameEndosseous dental implant abutment
Regulatory ClassClass II
Product CodeNHA
Classification PanelDental
Reviewing OfficeOffice of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices)
Reviewing DivisionDivision of Dental and ENT Devices

PREDICATE DEVICE INFORMATION

Primary Predicate Device K170588, DESS Dental Smart Solutions, Terrats Medical SL

Reference Devices K191986, DESS Dental Smart Solutions, Terrats Medical SL K212628, DESS Dental Smart Solutions, Terrats Medical SL K222288, DESS Dental Smart Solutions, Terrats Medical SL K212538, DESS Dental Implants, Terrats Medical SL K231434, DESS Dental Smart Solutions, Terrats Medical SL

6

Reference Devices for OEM implant body clearances

  • K140347, ANKYLOS C/X Implant System, Dentsply International Inc.
  • K120414. OsseoSpeed™ Plus, Astra Tech AB
  • K111287, Astra Tech Implant System Plus, Astra Tech AB
  • K101732, Astra Tech Implant System, Astra Tech AB
  • K042429, BioHorizons The Prodigy System™ Endosseous Implants, BioHorizons Implant Systems, Inc.
  • K071638, BioHorizons Tapered Internal Implant System, BioHorizons Implant Systems, Inc.
  • K093321, BioHorizons Laser-Lok 3.0 Implant System, BioHorizons Implant Systems, Inc.
  • K063341, 3i OSSEOTITE® Certain® Dental Implants, Implant Innovations, Inc.
  • K083496, CAMLOG Implant System Modified Implants and Abutments, Altatec GmbH
  • K160965, SuperLine, Dentium Co., Ltd.
  • K073075, FRIADENT Implant Systems (FRIALIT® plus Dental Implant System, XiVE® S plus Dental Implant System, XiVE® TG plus Dental Implant System, ANKYLOS® plus Dental Implant System), Dentsply International Inc.
  • K163194, Neodent Implant System GM Line, JJGC Indústria e Comércio de Materiais Dentários SA
  • K180536, Neodent Implant System GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A.
  • K201225, Neodent Implant System GM Helix Implants 7.0, JJGC Indústria e Comércio de Materiais Dentários S.A.
  • K142260, NobelActive®, Nobel Biocare AB
  • K173418, NobelParallel™ Conical Connection, Nobel Biocare AB
  • K050705, TiUnite Implants®, Nobel Biocare AB
  • K050406, NOBELSPEEDY™ Implants, Nobel Biocare USA LLC
  • K050258, Groovy Implants, Nobel Biocare AB
  • K023113, Replace TiUnite Endosseous Implant, Nobel Biocare USA, Inc.
  • K161604, OSSTEM Implant System, OSSTEM Implant Co., Ltd.
  • K173961, Straumann® BLX Implant System, Institut Straumann AG
  • K181703, Straumann® BLX Line Extension Implants, SRAs and Anatomic Abutments, Institut Straumann AG
  • K191256, Straumann BLX Ø3.5 mm Implants, Institut Straumann AG
  • K210855, Straumann BLX Implant System, Institut Straumann AG
  • K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Institut Straumann AG
  • K140878, Straumann® Bone Level Tapered Implants, Straumann USA, LLC
  • K130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, LLC
  • K013227. Screw Vent Implant: Tapered Screw Vent Implant. Sulzer Dental. Inc.
  • K072589, Tapered Screw-Vent Implant, 4.1mmD, Zimmer Dental, Inc.
  • K220978, TSXTM Implants, Biomet 3i LLC

The primary predicate device K170588, and the reference devices K191986, K212628, and K222288 are in support of substantial equivalence of the subject designs, material, manufacturing, and biocompatibility. The reference device K212538 is in support of substantial equivalence of the subject device sterilization, packaging, and shelf life.

INDICATIONS FOR USE STATEMENT

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

Compatible Implant SystemImplant Body Diameter, mmImplant Platform Name
Ankylos C/X3.5, 4.5, 5.52.52
3.03.0
3.63.6
Astra Tech EV4.24.2
4.84.8
5.45.4
Astra Tech OsseoSpeed™3.5, 4.03.5/4.0
4.5, 5.04.5/5.0
BioHorizons Internal3.8, 4.63.5
4.6, 5.84.5
5.85.7

Compatible Implant Systems

7

Compatible Implant SystemImplant Body Diameter, mmImplant Platform Name
Biomet 3i Certain®3.253.4
4.04.1
5.05.0
Biomet 3i OSSEOTITE®3.253.4
3.75, 4.04.1
5.05.0
Camlog3.83.8
4.34.3
Dentium SuperLine3.6, 4.0, 4.5, 5.0, 6.0, 7.03.3
FRIADENT XIVE®3.43.4
3.83.8
4.54.5
Neodent Grand Morse3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0Grand Morse (GM)
NobelActive®3.5NP
NobelReplace Conical
NobelParallel Conical4.3, 5.0RP
NobelReplace®3.5NP
4.3RP
5.0WP
Nobel Brånemark System®3.3NP
3.75, 4.0RP
5.0WP
Osstem TS3.5Mini
Hiossen TS4.0, 4.5, 5.0, 6.0, 7.0Regular
Straumann BLX3.5, 3.75, 4.0, 4.5RB
5.0, 5.5, 6.5WB
Straumann® Bone Level3.3NC
4.1, 4.8RC
Straumann® Tissue Level3.3, 4.1, 4.8RN
4.8WN
Zimmer Screw Vent®3.3, 3.7, 4.13.5
Tapered Screw-Vent®4.74.5
6.05.7
TSX™ Implant System3.7, 4.1, 4.74.5
5.4, 6.04.5

SUBJECT DEVICE DESCRIPTION

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.

The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws. A summary of the subject components is provided in the following table.

Subject Device Components
OEM Implant LinesHealing
AbutmentsTemporary
AbutmentsMunti-Unit
Abutments, 0°Munti-Unit
Abutments, 17° and
30°Screws
Ankylos C/XXXX
Astra Tech EVXXXXX
Astra Tech OsseoSpeed™XXXXX
BioHorizons InternalXX
Biomet 3i Certain®XXX
Biomet 3i OSSEOTITE®XXXX
CamlogXXX

8

Subject Device Components
OEM Implant LinesHealing
AbutmentsTemporary
AbutmentsMunti-Unit
Abutments, 0°Munti-Unit
Abutments, 17° and
30°Screws
Dentium SuperLineX
FRIADENT XiVE®XXX
Neodent Grand MorseXX
NobelActive®XXXXX
NobelReplace®XXXX
Nobel Brånemark System®XXXX
Osstem TSXX
Hiossen TSXX
Straumann BLXXXX
Straumann® Bone LevelXXXXX
Straumann® Tissue LevelXXXX
Zimmer Screw Vent®XXX
Tapered Screw-Vent®XXX
TSX™ Implant SystemXXX

Healing Abutments are compatible with the OEM implant lines as listed in this summary, and as protectors (healing attachments) for use with Straumann Converter Abutment for Straumann Tissue Level implants) and for DESS Multi-Unit Abutments. The Healing Abutments are provided in a range of gingival heights from 1 mm to 6.5 mm, and in a range of coronal (maximum) diameters of 3.5 mm to 7 mm.

Temporary Abutments are compatible with the OEM implant lines as listed in this summary and are available for single-unit and multiple-unit restorations. Temporary Abutments are provided in a range of gingival heights from 0.35 mm to 2.5 mm, and in a range of prosthetic platform diameters from 4.5 mm to 6.8 mm.

Multi-Unit Abutments are compatible with the OEM implant lines as listed in this summary in straight (00) and angled (17° and 30°) designs. Multi-Unit are provided in gingival heights from 1 mm to 6 mm for the straight (0°) designs, 2.5 mm to 4.5 mm for angled 17º designs, and 3.5 mm for the angled 30º designs.

Abutment screws are compatible with the OEM implant lines as listed in this summary. There are no changes to the design of the screws cleared previously in K170588. K212628. K191986, and K222288.

The subject device abutments and abutment screws have the same OEM implant compatibilities as the identical screws cleared in K170588, K212628, K191986, and K222288.

PERFORMANCE DATA

Non-clinical data submitted or referenced to demonstrate substantial equivalence included:

  • . non-clinical analysis was performed to evaluate the subject devices (including all abutments, abutment screw, and materials) in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque;
  • referenced from K212538 was gamma irradiation validation to a sterility assurance level of 10° by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2; bacterial endotoxin testing including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 to demonstrate that all sterile product meets a limit of