The Biodenta Dental Implant System Abutments is an extension and compatible to the Biodenta Dental Implant System Bone Level (K111003) which is an integrated system of endosseous dental implants, abutments and prosthetic parts and related surgical instruments.

The Biodenta Dental Implant System Abutments includes 3 abutment types:

Temporary PEEK abutments are manufactured of biocompatible PEEK plastic and used for temporary restorations for 180 days or less. They are attached to the dental implant using an abutment screw made of titanium alloy.

Swift Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Swift Abutments are designed in order that crowns and bridges can be attached by cement retention.

Sleeve Abutments are manufactured of biocompatible Titanium Alloy. The Abutments are attached to the implant by screwing them directly to the implant with the integrated screw thread. The Sleeve abutments are designed in order that bridges can be attached by screw retention.

All Abutments are straight abutments.

AI/ML Overview

The provided document is a 510(k) Summary for the Biodenta Dental Implant System Abutments. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria and statistical analysis as is common for AI/ML-based medical devices or more complex devices requiring clinical trials.

Therefore, the input document does not contain the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, or MRMC studies, standalone performance, or training/test set specifics.

The document primarily states:

Non-clinical Testing Data:
- No further fatigue testing was performed, referencing a guidance document for "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment." (This implies the device is presumed to meet performance standards if it meets the guidance's conditions, rather than requiring specific new fatigue tests).
- A sterilization validation was carried out according to ISO 14937:2009.
- Biocompatible raw materials were used, and chemical cleanness by XPS analysis and leachable cytotoxic substances (ISO 10993-5:2009) were investigated.
- A risk analysis was carried out, referencing the same guidance document.
Equivalence to marketed device: The report claims "substantial equivalence... in intended use, material composition, fundamental scientific technology, principles of operation, and basic design" to predicate devices. This is the core of a 510(k) submission, where direct performance metrics against acceptance criteria are often replaced by comparisons to devices already on the market.

Based on the provided text, I cannot complete the requested tables and information as it is not present in the document. The document describes a regulatory submission for a dental implant abutment, which relies on demonstrating equivalence to predicate devices and adherence to established standards for materials and sterilization, rather than performance studies with quantified acceptance criteria as typically seen for novel diagnostic or AI-driven devices.

Summary

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Image /page/0/Picture/0 description: The image shows the word "biodenta" in a bold, sans-serif font, with the registered trademark symbol to the right of the word. Above the word is a curved graphic element that resembles a crescent shape. At the top of the image is the text "K127559" which appears to be handwritten.

510(k) Summary

Owner's name:	Biodenta Swiss AG
Address:	Tramstrasse 169442 BerneckSwitzerland
Phone:	+41 71 747 11 11
Fax number:	+41 71 747 11 12
Contact person:	Mr. David Eiler, Regulatory Manager
Date summary prepared:	March 18, 2013
Trade / proprietary name:	Biodenta Dental Implant System - Abutments
Common name:	Endosseous dental implant abutment
Device classification name:	Abutment, Implant, Dental, Endosseous
Product code:	NHA
Regulation number:	21 CFR 872.3630

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ﺍﺳﺖ ﺩﺭ ﻣﺤﻤﺪ ﺍﺳﺖ. ﺩﺭ ﺳﺎﺯﯼ ﺍﺳﺖ. . . . . . . . . . . . . . . . . . . . . . . . . . Legally marketed device to which equivalence is claimed (predicate device):

Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Abutments

5 - 510(k) Summary

1. Company:	Biodenta Swiss AG
Device name:	Biodenta Dental Implant System - Bone Level
510(k) number:	K111003
2. Company:	Biohorizons Implant Systems, Inc.
Device name:	Biohorizons Plastic Temporary Abutments
510(k) number:	K053099

Revision 3.0 5
1 of 4 Section Section page

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Image /page/1/Picture/1 description: The image shows the word "biodenta" in a bold, sans-serif font. Above the word is a stylized graphic of three curved lines, stacked on top of each other. To the right of the word is a circled R symbol, indicating that the word is a registered trademark.

3. Company:	Zimmer Dental Inc.
Device name:	Plastic Temporary Abutments
510(k) number:	K092377
4. Company:	Implant Direct LLC.
Device name:	Spectra System Dental Implants 2008
510(k) number:	K090234

Indications for Use:

Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for fixed or removable crown or bridgework.

Device Description:

The Biodenta Dental Implant System Abutments includes 3 abutment types:

All Abutments are straight abutments.

Non-clinical Testing Data:

The Biodenta Dental Implant System Abutments do not include angled abutments. Following the quide "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment" (May 12, 2004) no further fatigue test was performed.

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Abutments 5 - 510(k) Summary

Image /page/2/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a sans-serif font, with a registered trademark symbol to the right of the word. Above the word is a graphic of three curved lines, stacked on top of each other.

A sterilization validation according to ISO 14937:2009 and a residual moisture validation was carried out to confirm the recommended sterilization parameters and drying time.

Biocompatible raw materials have been used for manufacturing the abutments. The final products have been investigated on the chemical cleanness by an XPS analysis and on leachable cytotoxic substances (according to ISO 10993-5:2009) to determine the effects of the manufacturing process to the materials. The results demonstrate that the final products after manufacturing are considered to be biocompatible.

A risk analysis following the guide "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseus Dental Implant Abutment" (May 12, 2004) has been carried out. The implemented mitigations measures were found being suitable to reduce the residual risks to an acceptable level.

Equivalence to marketed device:

Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Dental Implant System Abutments is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.

The summary table for the Substantial Equivalence Comparison to predicate devices is attached on the following page

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Premarket Notification / 510(k) Submission
Biodenta Dental Implant System – Abutments
5 - 510(k) Summary

and the contraction of the comments of the comments of the

Image /page/3/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Above the word is a stylized graphic of three curved lines, stacked on top of each other.

	Subject Device			Predicate Devices
Device Name	Biodenta Dental ImplantSystem - Abutments	Biodenta Dental ImplantSystem - Bone LevelK111003	Biohorizons PlasticTemporary AbutmentsK053099	Zimmer Dental Inc.Plastic Temporary AbutmentsK092377	Implant Direct LLC.Spectra System Dental Implants 2008K090234
Intended Use
Intended use	Biodenta Dental ImplantSystem Abutments areintended for terminal orintermediate abutmentsupport for fixed orremovable crown orbridgework	Biodenta bone level dentalimplants are intended forsurgical placement inmandibles or maxillae tosupport single or multipletooth restorations orterminal or intermediateabutment support for fixedor removable bridgeworkand to retain overdentures.	BioHorizons PlasticTemporary Abutments areintended for short-term useof 30 days or less as abase for cemented orscrew-retained crown andbridge restoration of dentalimplants, while estheticallycontouring soft tissue.	The Plastic Temporary Abutment isintended to be used to fabricateandsupport provisional restorations thataid increating an esthetic emergencethrough the gingiva during the healingperiod and prior to final restoration. ThePlastic Temporary Abutment can be usedfor cement-retained or screw-retainedprovisional restoration. The abutmentscan be used for single-unit and multi-unitrestorations. Use of the Plastic TemporaryAbutment is not to exceed one-hundredand eighty (180) days.	The Spectra-System Dental Implant 2008system is comprised of dental implant fixturesand prosthetic devices that compose a two-piece implant system. The Dental Implants areintended for use in the mandible and maxilla,in support of single unit or multiple unit cementor screw-receiving restorations and for theretention and support of overdentures. Theimplants are intended for immediate placementand function for the support of single-tooth ormultiple-tooth restorations, recognizing bonestability and appropriate occusal loadrequirements.
Basic Design
Abutment Type	Temporary & FinalAbutments	Temporary & FinalAbutments	Temporary Abutments	Temporary Abutments	Final Abutments
Abutment asImpression Post	Yes	No	No	No	Yes (fixture mount used as impressionpost and abutment)
Abutment Type	StraightAbutments	Straight & AngledAbutment	StraightAbutment	Straight & AngledAbutment	Straight Abutments
Abutment Angle	0°	0°-15°	0°	0°-17°	0°
Implant / Abut.Connection	Internal Hexagon	Internal Hexagon	Internal Octagon	Internal Hexagon	Internal Hexagon
TemporaryAbutment Diameter	4.0 mm6.5 mm	3.5 mm3.7 mm	3.5 mm4.5 mm5.5 mm6.5 mm	4.5 mm5.5 mm6.5 mm	--
TemporaryAbutment Height	9.8 mm	7.0 mm	10.5 mm	8.0 mm	--
FinalAbutment Diameter	3.7 - 5.5 mm	3.5 - 6.0 mm	--	--	4.8 - 6.6 mm
FinalAbutment Height	1.5 - 12 mm	5.7 - 9.8 mm	--	--	6.5 mm
MaterialTemporary Ab.Material	biocompatible PEEK	Titanium Alloy	biocompatible PEEK	biocompatible PEEK	--
TerminalAb. Material	Titanium Alloy	Titanium Alloy	--	--	Titanium Alloy
Sterilization	Provided Non-Sterile	Provided Non-Sterile	Provided Non-Sterile	Provided Non-Sterile	Provided sterile with implant packaging
Reuse	Single use	Single use	Single use	Single use	Single use

evision 3.
Section 5.

Revision

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2013

Mr. David Eiler Regulatory Manager Biodenta Swiss AG Tramstrasse 16 Berneck, Switzerland 9442

Re: K122559

Trade/Device Name: Biodenta Dental Implant System Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 30, 2013 Received: May 1, 2013

Dear Mr. Eiler:

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. The general controls provisions of the Act include requirements for annual registration. Ilsting 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer-S
2013.05.03 11:27:36 -04'00'
for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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Premarket Notification / 510(k) Submission Biodenta Dental Implant System - Abutments 4 - Indications for Use Statement

Image /page/6/Picture/1 description: The image shows the word "biodenta" in a bold, sans-serif font. Above the word is a stylized graphic that appears to be a curved shape with textured details. To the right of the word "biodenta" is a circled R symbol, indicating that the word is a registered trademark.

Indications for Use

510(k) Number (if known):

Device Name: Biodenta Dental Implant System Abutments

Indications for Use:

Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for fixed or removable crown or bridgework.

///22559

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner, DDS, MA

Digitally signed by Mary S. Runner -5

DN: c=US, o=U.S. Government,

ou=HHS, ou=FDA, ou=People, cn=Mary

S. Runner

0.9.2342.19200300.100.1.1-130008795

Date: 2013.05.02 11:39:22 -04'00

(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510(k) Number:	K122559
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	Revision 1.0
	Section 4
	Section page 2 of 5

Regulation Number and Section

§ 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.)