The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).

Device Description

The B.A.S.I.C. Dental Implant is an endosseous dental implant. The implant, healing cap and healing screws will now be provided in a sterilized medical grade Tyvek® pouches in accordance with ISO 11137 (SAL 10to). In addition, implants are now provided in diameter of 6.0 mm and lengths of 8.0 mm and 9.0 mm to provide a wider range of options for the dental professional.

AI/ML Overview

The provided text is a 510(k) summary for the B.A.S.I.C. Dental Implant System. It describes modifications to an existing device rather than a new device that requires a comprehensive clinical study with acceptance criteria and a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not explicitly available in this document.

However, based on the context of a 510(k) submission, the "acceptance criteria" are implied to be substantial equivalence to a predicate device, meaning the modified device performs as safely and effectively as a legally marketed device and does not raise new questions of safety or effectiveness. The "study" proving this is primarily a comparison to predicate devices and adherence to relevant standards, rather than a clinical trial with performance targets.

Here's an attempt to answer the questions based on the provided text, recognizing the limitations of a 510(k) summary for device modification:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for device modifications aiming for substantial equivalence rather than a new device with specific performance claims from a clinical trial, the "acceptance criteria" are primarily met through comparison to predicate devices and adherence to standards.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance and Evidence (from 510(k) Summary)
No change in Intended Use (Safety & Effectiveness maintained for original purpose)	"The intended use is identical to the predicate device."
No alteration of fundamental scientific technology	"Per FDA-CDRH criteria for a Special 510(k), the modifications do not affect the intended use or alter the fundamental scientific technology of the device..."
Equivalent technological characteristics (despite modifications)	The updated specifications (new diameters and lengths, sterilized components) are deemed substantially equivalent or improvements, as detailed in the comparison tables.
No new health risks posed by modifications	"Risk analysis which includes health risks related to root form endosseous dental implants... An FMEA report is included in Attachment 9.""The dimensional specification changes do not pose any new health risks to the patient as there are other cleared products on the market with similar dimensions."
Sterilization effectiveness (for new sterilized components)	"B.A.S.I.C. Dental Implant Systems, Inc. has contracted with Steris Isomedix Service to establish and maintain a valid gamma-ray sterilization processes in accordance with ISO 11137 (SAL 10⁻⁶)... Substantiation of a routine sterilization dose was established using the VDmax's method, described in ISO 11137."
Biocompatibility maintained (as material is unchanged)	"Material of Implants: CP Titanium" (unchanged). This implies continued biocompatibility of the material.
Device integrity and functionality maintained (post-sterilization, new dimensions)	"Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. The B.A.S.I.C. Dental Implant System meets B.A.S.I.C.'s in-house requirements..."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a traditional clinical "test set" in the document. The "samples" referenced for sterilization and device integrity validation are "produced under routine manufacturing conditions," but the quantity is not specified.
Data Provenance: Not applicable in the context of a clinical study. The data provenance relates to internal testing (sterilization validation, FMEA, in-house requirements) and comparison to existing market data (other cleared devices). This is retrospective in the sense of looking at existing cleared devices and standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. Ground truth in this context is established by adherence to recognized standards (ISO 11137, FDA Guidance) and comparison to legally marketed predicate devices, rather than expert consensus on a specific test set.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no clinical PIVOTAL trial of read performance to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done or required for this 510(k) submission. This type of study is typically associated with new diagnostic devices or AI algorithms where human reader performance is a key outcome.
Effect Size: N/A.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Standalone Study: No, this is not an AI/algorithm-based device. No standalone performance study in that sense was conducted or described.

7. Type of Ground Truth Used

Ground Truth: For this device modification, the "ground truth" is established by:
- Regulatory Standards: Compliance with ISO 11137 for sterilization, and internal requirements for device integrity and functionality.
- Predicate Device Equivalence: The existence and safety/effectiveness of previously cleared devices (both the unmodified B.A.S.I.C. Dental Implant System and other manufacturers' devices) with similar dimensions and characteristics serve as the de facto "ground truth" for the new design's safety and effectiveness.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable.

Summary

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K072545

510(k) SUMMARY III.

1. SUBMITTER INFORMATION A. Company Name: B.A.S.I.C. Dental Implant Systems, Inc. B. Company Address: 3321 Columbia NE Albuquerque, NM 87107 USA · C. Company Phone: (505) 881-1376 D. Company Facsimile: (505) 884-1923 E. Company Contact: Dan Blacklock 。 Vice President 2. DEVICE IDENTIFICATION A. Device Trade Name: B.A.S.I.C. Dental Implant System B. Device Common Name: Dental implant C. Classification Name: Endosseous Dental Implant, root-form D. Device Class: Class II E. Device Code: DZE 3. MODIFIED FROM DEVICE Trade Name: BASIC Dental Implant System

510(k) Number:

K013682

MAY - 9 2008

of qc

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510(k) SUMMARY (continued) III.

4. DEVICE DESCRIPTION & SUMMARY OF DEVICE MODIFICATIONS

The B.A.S.I.C. Dental Implant is an endosseous dental implant.

The implant, healing cap and healing screws will now be provided in a sterilized medical grade Tyvek® pouches in accordance with ISO 11137 (SAL 10to).

In addition, implants are now provided in diameter of 6.0 mm and lengths of 8.0 mm and 9.0 mm to provide a wider range of options for the dental professional. Per Section 6 of FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Abutments", Dated May 12, 2004, BASIC has conducted a risk analysis which includes health risks related to root form endosseous dental implants. An FMEA report is included in Attachment 9. Furthermore, there are many other cleared root form endosseous dental implants on the market with similar dimensions (Refer to Section 7 of this summary).

There have been no further modifications to the dental implant system.

Per FDA-CDRH criteria for a Special 510(k), the modifications do not affect the intended use or alter the fundamental scientific technology of the device and the modifications to the device fall within the design controls of the device.

INTENDED USE 5.

The intended use is identical to the predicate device. For reference the intended use is listed below.

The implant for dental purposes, used to replace missing dental organs (teeth). The Implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the Implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).

COMPARISON TO PREDICATE DEVICE (UN-MODIFIED DEVICE) 6.

The B.A.S.I.C. Dental Implant is substantially equivalent in the following ways to the identified predicate device:

Identical technological characteristics
Identical Indications For Use

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III. 510(k) SUMMARY (continued)

6. COMPARISON TO PREDICATE DEVICE (UN-MODIFIED DEVICE), continued

The table below summarizes primary characteristics of the original B.A.S.I.C. Dental Implant and the modified device:

Device Name	B.A.S.I.C. DentalImplant	B.A.S.I.C. DentalImplant-DeviceModification	Equivalence Comparison(SE= Substantial Equivalent)
510(k) Number	K013682	Pending	N/A
Implant Diameter	3.5 mm, 4.0 mmand 4.5 mm	3.5 mm, 4.0 mm,4.5 mm and 6.0mm	SE¹:Change in dimensionalspecification, implant diameter
Implant Length	11 mm, 13 mmand 15 mm	8 mm, 9 mm,11mm, 13 mmand 15 mm	SE¹:Change in dimensionalspecification, implant length
SterilizedComponents	All componentsprovided non-sterilized.	Implant, healingcap and healingscrews areprovidedsterilized.	SE²:Implantable components areprovided sterilized inaccordance with ISO 11137(SAL 10⁻⁶) for ease of use.
Material of Implants	CP Titanium.	CP Titanium	SE¹:
Packaging of Implant	Implantablecomponentsprovided in a non-sterile packagewith instructionsto autoclave forsterilization.	Implantablecomponentsprovided insterilized medicalgrade Tyvek®pouches.	Product improvement

1 The modification to the dimension and length of the implant does not change the intended use or the fundamental scientific technology of the system. The modification allows for a wider range of options of the dental professional. Diagrams of the implants are provided in Attachments 4-8.

2 The modification to provide the implantable components sterilized does not change the intended use or the fundamental scientific technology of the system. The modification enables dental professionals without easy access to an autoclave to be able to use the implant in a safe and effective manner.

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III. 510(k) SUMMARY (continued)

7. COMPARISON TO OTHER PREDICATE DEVICES

For reference BASIC is including a summary of other predicate devices with cleared implants of similar dimensions, which demonstrate the changes to the dimensional specifications for the implants pose no new health risks to patients.

Device Name	510(k)Number	Device Description	EquivalenceComparison
B.A.S.I.C. DentalImplant-DeviceModification	Pending	Implants offered in diameter sizes of 3.5 mm,4.0 mm, 4.5 mm and 6.0 mm. Implantsoffered in lengths of 8 mm; 9 mm; 11mm, 13mm and 15 mm
3i Osseotite	K063341	Implants are offered in diameter sizes 3.25mm, 3.75 mm, 4.0 mm, 5.0 mm and 6.0 mmand in varying lengths from 7 mm to 20 mm.	SE
ImplantInnovations	K051189	Implants are offered in diameter sizes 3.25mm to 6.0 mm and with lengths from 8.5 mmto 15 mm.	SE
Bicon	K972417	Implants are offered in 6.0 mm diameter x 8.0mm length	SE

8. STERILIZATION AND BIOCOMPATIBILITY

B.A.S.I.C. Dental Implant Systems, Inc. has contracted with Steris Isomedix Service to establish and maintain a valid gamma-ray sterilization processes in accordance with ISO 11137 (SAL 104) for its B.A.S.I.C. Dental Implant System. Substantiation of a routine sterilization dose was established using the VDmax's method, described in ISO 11137.

Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. The B.A.S.I.C. Dental Implant System meets B.A.S.I.C.'s in-house requirements, and requirements listed in ISO 11137, Gamma sterilization for the implantable components, which are now rovided in sterilized medical grade Tyvek® pouches.

9. CONCLUSION

The B.A.S.I.C. Dental Implant System is substantially equivalent to the original nonmodified device. The previously cleared dental implant design and the programed dental implant design serve the same intended purpose, are made of the same materials, use the same techniques, and are restored by the dentist using the same methods. The gamma sterilization method used for implantable components is is an improvement to the Basic Dental Implant System since the implantable components were not supplied sterilized before. The dimensional specification changes do not pose any new health risks to the patient as there other cleared products on the market with similar dimensions.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

B.A.S.I.C. Dental Implant Systems, Incorporated C/O Mr. Rich Weiskopf Director Quality Assurance Reglera LLC 555 Zang Street, Suite 100

Lakewood, Colorado 80228

Re: K072595

Trade/Device Name: B.A.S.I.C. Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 7, 2008 Received: April 10, 2008

Dear Mr. Weiskopf:

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.

MAY - 9 2008

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.

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Page 2 - Mr. Weiskopf

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); 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.

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.

Syute y. Michaud.

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

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Indications for Use

510(k) Number (if known): K072595

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Prescription Use XXX (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)

Ke Huley for MSN
(Division Sign-Off)

Page 1 of

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: -072595

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.