CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

Device Description

This submission covers a series of abutments for the CAMLOG Implant System, including a straight crown and bridge abutment, a prepable abutment, a conical abutment, a cast-on abutment, and a temporary abutment.

AI/ML Overview

This 510(k) summary for the CAMLOG Implant System Abutments is a submission for a new medical device seeking clearance based on substantial equivalence to an existing predicate device. As such, it does not contain specific acceptance criteria and a study demonstrating the device meets those criteria in the way one would expect for a de novo submission or a clinical trial report.

Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The "study" mentioned here is the comparison made by the manufacturer to establish this equivalence.

Here's an breakdown based on the provided document, addressing the requested points:

Acceptance Criteria and Device Performance (in the context of a 510(k) submission)

This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria for new device functions. The "acceptance criteria" implicitly revolve around meeting the design principles and indications for use of the predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Implicit for 510(k))	Reported Device Performance (as stated in submission)
Indications for Use Equivalence	"CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch." (Matches predicate indications)
Design Principles Equivalence	"Altatec GmbH demonstrated that... CAMLOG Implant System Abutments are substantially equivalent in... design principles to predicate devices..."
Material Equivalence (Implied)	Not explicitly stated in this summary, but would be part of the substantial equivalence documentation.
Biocompatibility (Implied)	Not explicitly stated in this summary, but would be part of the substantial equivalence documentation.
Mechanical Performance (Implied)	Not explicitly stated in this summary, but would be part of the substantial equivalence documentation (e.g., fatigue strength, retention).

Study Details (Relevant to 510(k) Substantial Equivalence)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set: For a 510(k) based on substantial equivalence for a device like this, there isn't typically a "test set" of patient data in the clinical trial sense. The "test" is a comparison of the new device's specifications (design, materials, indications for use, performance data from bench testing if applicable) against those of the predicate device(s). The document doesn't provide details on specific bench tests or "test set" sizes for clinical performance.
- Data Provenance: Not applicable in the context of clinical patient data for this type of submission. The data would primarily be engineering specifications and potentially bench test results.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" in the sense of clinical expert consensus would not be established for a 510(k) substantial equivalence submission for mechanical dental abutments. The assessment is made by the manufacturer and reviewed by the FDA based on documented comparisons to predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical adjudication method described for a "test set" in this 510(k) submission.
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 a physical dental implant abutment, not an AI/software device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental implant abutment, not an AI/software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the clinical sense. The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared. This is based on regulatory standards and previous FDA clearances.
The sample size for the training set:
- Not applicable. Training sets are relevant for AI/machine learning algorithms. This device is a physical medical device.
How the ground truth for the training set was established:
- Not applicable. (See #7).

Summary of the "Study" for this 510(k) Submission:

The "study" that proves this device meets the "acceptance criteria" (i.e., substantial equivalence) is the comparison report submitted by Altatec GmbH to the FDA. This report would detail:

Comparison of Indications for Use: Showing they are identical or very similar.
Comparison of Technological Characteristics: This would include design, materials, dimensions, manufacturing processes, and possibly results from non-clinical performance testing (e.g., mechanical strength, fatigue, biocompatibility testing if new materials are used or if a new combination of materials is present).
Performance Data: Presenting any bench testing or engineering analysis demonstrating that the new device performs as safely and effectively as the predicate devices under intended use conditions.

The document states: "Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices, CAMLOG Implant System Abutments are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices." This sentence is the core "proof" summarized in this public document, with the full details residing in the confidential 510(k) submission.

Summary

{0}------------------------------------------------

43553

CAMLOG Implant System Abutments

510(k) Summary

MAR - 5 2008

Altatec GmbH CAMLOG Implant System Abutments

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Altatec GmbH
	Maybachstrasse 5
	D-71299 Wimsheim, Germany
	Telephone: +49 7044-9445-0
	Fax: +49 7044-9445-722
Official Contact:	Tina Steffanie-Oak
	CAMLOG USA
	Telephone: +1 (717) 335-7230
	Fax: +1 (717) 335-7240
	Email: Tina.Steffanie-Oak@henryschein.com
Representative/Consultant:	Linda K. Schulz or
	Floyd G. Larson
	PaxMed International, LLC
	11234 El Camino Real, Suite 200
	San Diego, CA USA 92130
	Telephone: +1 (858) 792-1235
	Fax: +1 (858) 792-1236
	Email: lschulz@paxmed.com
	flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	CAMLOG Implant System Abutments
Common Name:	Dental implant abutments
Classification Regulations:	Endosseous dental implant abutment
	21 CFR 872.3630, Class II
Product Codes	NHA
Classification Panel:	Dental Products Panel
Reviewing Branch:	Dental Devices Branch

{1}------------------------------------------------

INTENDED USE

CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices, CAMLOG Implant System Abutments are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Altatec GmbH C/O Ms. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

MAR - 5 2008

Re: K073553

Trade/Device Name: CAMLOG Implant System Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 17, 2007 Received: December 18, 2007

Dear Ms. Schulz:

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, 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 (PMA), it may be subject to such 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.

{3}------------------------------------------------

Page 2 - Ms. Schulz

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 liederal 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Snytte y. Miakem Oms

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

CAMLOG Implant System Abutments

Indications for Use

510(k) Number (if known):

CAMLOG Implant System Abutments Device Name:

Indications for Use:

CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.

Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

Page

510(k) Number:

C673532

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.)