The bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.

Device Description

The orthodontic bonding base is screwed onto the ITI Octa system. The bonding base has an interior icositetrahedron (24 facets) which allows a positioning in the desired angulation (15° steps). The bonding surfaces are eccentric to the implant axis such that four different distances are available between implant axis and bonding surface. An orthodontic bracket is cemented to the orthodontic bonding base and it acts as an anchor for the application of orthodontic forces during treatment. After orthodontic use, the bonding base is removed and a standard prosthetic restoration placed on the implant.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bonding Base Orthodontic Bonding Base:

Based on the provided 510(k) summary, formal acceptance criteria and a structured study demonstrating performance against those criteria are not explicitly detailed in a way that would be typical for a modern medical device submission. This document pre-dates many of the more rigorous requirements for clinical evidence and performance studies that are common today.

The "study" presented here is a demonstration of substantial equivalence to predicate devices, which is the primary pathway for 510(k) clearance. The acceptance criteria are implicitly met by showing that the device is similar in intended use, materials, and design to devices already on the market, and therefore, it is considered as safe and effective as those legally marketed devices.

Here's a breakdown of the requested information based on the provided text, with points that cannot be determined clearly marked:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate devices. The "reported device performance" is a comparison to these predicates rather than an independent measure against objective benchmarks.

Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use: Serve as a base for orthodontic attachment.	The device's intended use is identical: "Serve as a base for orthodontic attachment." (Matches 3M Unitek Orthodontic Bands).
Materials: Biocompatible and suitable for dental use.	The device uses Titanium. (Compared to Stainless Steel for 3M bands, and Titanium/gold alloy for other ITI copings. Titanium is a well-established biocompatible material for dental implants and components).
Design: Mechanically sound, allows proper fit and function with ITI Octa system and orthodontic brackets.	Heights: 5.5 mm and 6.5 mm. Width: 6.8 mm.Internal icositetrahedron (24 facets): For seating on Octabutment.Axial screw channel: For attachment to abutment. These design features are comparable in principle to the designs of the predicate ITI copings (e.g., internal icositetrahedron, screw channels) and fulfill the basic mechanical requirements implied by the functional description. (Matches features for attachment to implant system).

Study Details for Substantial Equivalence

The "study" here is the comparison table for substantial equivalence, not a typical performance study with patients or controlled laboratory tests against predefined success/failure criteria.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable in the context of a comparative substantial equivalence study based on design and materials. No test set of patient data or device performance data is described for this comparison.
Data Provenance: Not applicable. The comparison is against the specifications and known characteristics of legally marketed predicate devices, not empirical data from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in the sense of expert consensus on patient outcomes or interpretations, was not established for this type of submission. The "ground truth" for the comparison is the publicly available information and regulatory clearance status of the predicate devices.

4. Adjudication method for the test set:

Not applicable. There was no test set requiring multi-expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI/imaging device, and no MRMC study was performed or required for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. Not an algorithm or AI device.

7. The type of ground truth used:

The "ground truth" used for this submission is the regulatory status and descriptive characteristics of legally marketed predicate devices. The argument is that because the new device is sufficiently similar to these cleared devices, it can be considered safe and effective.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device, so there is no training set in that context. The device design and materials were likely developed through engineering design processes, possibly including bench testing, but these are not described as a "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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DEC - 2 1997

KA73353

ATTACHMENT 7

510(k) Summary

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ATTACHMENT 7 - 510(k) Summary

Applicant's Name and Address 1.

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02154 781-890-0001 Telephone Number: Fax Number: 781-890-6464 Linda Jalbert, Director of Regulatory Affairs Contact Person:

2. Name of the Device

Trade Name: Bonding Base Orthodontic Bonding Base Common Name: Accessory to a dental implant (21 CFR 872.3640) Classification Name:

3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)

ITI Titanium Transverse Screw Coping (K943720) ITI Octa Gold Coping (K894844) 3M Unitek orthodontic bands

4. Description of the Device

The orthodontic bonding base is screwed onto the ITI Octa system. The bonding base has an interior icositetetrahedron (24 facets) which allows a positioning in the desired angulation (15° steps). The bonding surfaces are eccentric to the implant axis such that four different distances are available between implant axis and bonding surface. An orthodontic bracket is cemented to the orthodontic bonding base and it acts as an anchor for the application of orthodontic forces during treatment. After orthodontic use, the bonding base is removed and a standard prosthetic restoration placed on the implant.

ട. Intended Use of the Device

The bonding base serves as an attachment surface for the cementing of orthodontic brackets.

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Basis for Substantial Equivalence 6.

The Orthodontic Bonding Base is substantially equivalent to 3M Unitek Orthodontic The Orthodonitic Donaing Daos to babotantially oquivalism to on Children in the ITI Dands, the TTP Thankin Transverstooners on, material and design as follows:

	SubjectDevice	Predicate Devices
Features	OrthodonticBondingBase	3M UnitekOrthodonticBands	ITI TitaniumTransverseScrewCoping	ITI Octa GoldCoping	ITITransverseScrew GoldCoping
IntendedUse	Serve as a basefor orthodonticattachment	Serve as abase fororthodonticattachment	Serve as a basefor prostheticreconstruction	Serve as a basefor prostheticreconstruction	Serve as abase forprostheticreconstruction
Materials	Titanium	Stainless Steel	Titanium	gold alloy	gold alloy
Design	Heights of 5.5mm and 6.5 mm.Width of 6.8 mm.Internalicositetrahedron(24 facets) forseating onOctabutment.Axial screwchannel forattachment toabutment.	Tooth-shapedcircular bandsdesigned in arange of sizestoaccommodatevarying toothanatomies andsizes.	Height of 8.0mm.Internalicositetrahedron (24 facets) forseating onOctabutment.Transversescrew channelfor attachmentto abutment	Height of 4.0mm.Internal octagonfor seating onOctabutment.Axial screwchannel forattachment toabutment.	Height of 5.2mm.Internalicositetrahedron (24 facets)for seating onOctabutment.Transversescrew channelfor attachmentto abutment.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1997

Ms. Linda Jalbert Director, Requlatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road 02154 Waltham, Massachusetts

Re : K973353 Trade Name: Bonding Base Regulatory Class: III Product Code: DZE Dated: September 4, 1997 Received: September 5, 1997

Dear Ms. Jalbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Jalbert

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-20#1 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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510(k) Number (if known):	K973353
Device Name:	Bondin base
Indications For Use:

Page ofThe bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.

. .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign Off)
Divi- Division of Reproductive, Abdominal, and Radiological Devices Control,
and Division of Reproductive, Abdominal, and Radiological Devices al Devices

510(k) Number	K973353
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Prescription Use Vse (Per 21 CFR 801.109)

Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.