This device 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, and to restore the patient's chewing function. It may be used for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading.

This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

These devices are intended for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge installations for full or partial edentualism such as: Support anchors for temporary restorations during the healing and osseointegration process of permanent implants. Immediate loading temporary abutments for repairing failing tooth and implant supported restorations. Transitional supports for immediate replacement of missing teeth, For use in front maxilla where 4 or more implants are splinted together, may be loaded immediately.

Device Description

This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant in various procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.

This device is an endosseous dental implant consisting of the major component, a root-form, screw type implant with a specialized head, and accessories, designed to facilitate placing and using the implant in orthodontic procedures.. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are described in Quality System documentation.. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head has a 0.7 mm aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The JJG Evolution™ Orthodontic implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.

This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ Monoblock Implant system is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.

AI/ML Overview

The provided text is a 510(k) summary for the J.J.G. Evolution™ Mini-Implant System, Orthodontic Implant System, and Monoblock Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, many of the requested sections about specific study details (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication method, MRMC study, standalone performance, ground truth type and establishment) cannot be extracted from the provided document as this type of information is generally not part of a 510(k) summary for devices demonstrating substantial equivalence based on material and design similarity.

The document states: "No performance standards are applicable, however we followed 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' issued May 12, 2004." This indicates that compliance is primarily based on meeting material specifications and functional similarity to predicates, rather than proving specific performance metrics through a clinical study.

Here's a summary of what can be extracted:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are primarily based on substantial equivalence to legally marketed predicate devices, as defined by the FDA's "510(k) 'Substantial Equivalence' Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3." This means the devices must have the same intended use and similar technological characteristics (materials, design, manufacturing concepts) as their predicates.

The study presented is essentially a comparison to predicate devices rather than a performance study against numerical acceptance criteria.

Acceptance Criteria (based on Substantial Equivalence)	Reported Device Performance
Same Intended Use (for each system):	Met:
- Mini-Implant System: For intra-bony and inter-radicular transitional applications including support anchors for temporary restorations, immediate loading temporary abutments, transitional supports for immediate replacement of missing teeth, and immediate loading in front maxilla where 4+ implants are splinted.	"These products have the same intended use as predicate devices..." (e.g., Dentatus MTI, Sendax MDI)
- Orthodontic Implant System: To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth, used temporarily and removed after treatment.	"These products have the same intended use as predicate devices, intended to provide a fixed anchorage point for attachment of orthodontic appliances..." (e.g., Alpha-Bio Tec, Dentaurum, Straumann Ortho implant)
- Monoblock Implant System: To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained, intended for immediate implantation in extraction sites and immediate loading.	"These products have the same intended use as predicate devices..." (e.g., Zimmer One Piece Implant, Astra Tech, Nobel Biocare)
Similar Technological Characteristics (for each system):	Met:
- Material Composition: Titanium or titanium alloy (CP titanium meeting ASTM F-67, titanium alloy meeting ASTM F-136).	"manufactured from either titanium or titanium alloy." (Mini-Implant report) "made of titanium or titanium alloy, both of which meet FDA recognized consensus standards." (Orthodontic and Monoblock reports) "The materials (titanium and titanium alloy) are identical to some of the implants, and similar to those of the others made of titanium alloy."
- Design and Manufacturing Concepts: Screw-type, self-tapping, root-form, one-piece implants with various head shapes and dimensions (e.g., 1.5 to 2.8mm diameter, 10 to 20mm length for Mini-Implants). Specific features like grooves for elastics on Orthodontic implants, or roughened root form and smooth neck for Monoblock implants.	"They are screw-type, self-tapping endosseous dental implants with design and manufacturing concepts and materials similar to those of the predicate devices." (Mini-Implant report) "Like the Jeil Medical Dual Top system, they have a rounded head with a groove around it for the attachment of elastics, chains or coil springs." (Orthodontic report) "Like several of the predicate devices, the J.J.G. Evolution™ Monoblock Implants are post-type, tapered form, with spirals... manufactured with the root form treated to roughen it or otherwise hasten osseointegration, a smooth 'neck' to hasten tissue attachment..." (Monoblock report)
Compliance with Consensus Standards/Guidance:	Met: Compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ASTM F-67 / F-136.

Study Details

Sample size used for the test set and the data provenance:
- Not applicable/Not provided. The submission is based on a comparison of device characteristics and intended use to existing predicate devices, not a clinical trial or performance study with a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth in the context of a dataset is not relevant for this type of substantial equivalence submission.
Adjudication method for the test set:
- Not applicable/Not provided.
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/Not provided. This is not a study involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is not an algorithm-based device.
The type of ground truth used:
- Not applicable/Not provided. The "ground truth" here is regulatory compliance and functional similarity to established predicate devices, rather than a clinical outcome or diagnostic truth.
The sample size for the training set:
- Not applicable/Not provided. There is no training set mentioned, as this is not a machine learning or statistical model.
How the ground truth for the training set was established:
- Not applicable/Not provided.

Summary

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K072917

510(k) SUMMARY

Submitter: Mario Gersberg, Pres. Odontit S.A. Buenos Aires, Argentina,

Phone: + 5411-4825-0221.
Classification Name and Number: Endosseous Implant (DZE) 1.
1. Common/Usual Name: Mini-implants
Proprietary Name: J.J.G. Evolution™ Mini-Implant System. III.
IV. Registration No.: 9680963
V. Compliance with Performance Standards: No performance standards are applicable, however we followed "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" issued May 12, 2004. The CP titanium used in these implants meets ASTM F - 67 "Specification for Unalloyed Titanium for Surgical Implant Applications," and the titanium alloy meets ASTM F - 136. "Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical implant Applications."
VI. Description of the Device: This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant in various procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.
VII. Labels and Labeling: Draft labels of the JJG Evolution ' Mini-Implant system and instructions for use are provided.
Substantial Equivalence: The JJG Evolution™ Mini-Implant system is VIII. substantially equivalent to several small implant systems currently on the market. Some of these are: Dentatus MTI Modular Transitional Implants cleared in K980620, MTI-MP Transitional Implants, cleared by Dentatus USA in K961704, Sendax MDI cleared by Sendax MDIC Management in K972351, the Bicortical Screw, cleared by Oraltronics in K983120, and

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3i Strid Threaded/Self Tapping, Threaded/3i Miniplants, cleared by Implant Innovations, Inc., in K960417.

JJG Evolution™ Mini-Implants are substantially equivalent to the Dentatus MTI implants in that they are manufactured from either titanium or titanium alloy. Like the Dentatus and Sendax implants (K980620, K972351) the JJG Evolution™ Mini-Implants are also one-piece, self-tapping and feature various head-types. They have diameters ranging from 1.5 to 2.8 in diameter (less than the more typical endosseous implants commonly used with abutments) and range in length from 10 to 20 mm while the Sendax implants range from 14 to 22 mm (overall) and the Dentatus implant are 14 to 2 mm. in length (including the head portion).

The JJG Evolution™ Mini-Implants are also substantially equivalent to several other endosseous implants cleared in 510(k)s but differ somewhat in use from regular endosseous implants. Like the Sendax implants, JJG implants may be used for transitional or long-term implantation to support prosthetics (single tooth, crown or bridge cases) to provide for mastication. If four are placed in the front maxilla and splinted together, they may be loaded immediately.

The implant is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE: Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use as predicate devices, intended to provide These devices are intended for intra-bony and interradicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge installations for full or partial edentualism such as:

Support anchors for temporary restorations during the healing and osseointegration process of permanent implants; Immediate loading temporary abutments for repairing failing tooth and implant supported restorations;Transitional supports for immediate replacement of missing teeth; and for use in front maxilla where 4 or more implants are splinted together, may be loaded immediately.

The technological characteristics for this product are similar (nearly identical) to those of the predicate devices and those currently on the market They are screw-type, self-tapping endosseous dental implants with design and manufacturing concepts and materials similar to those of the predicate devices.

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KC72917

510(k) SUMMARY

Submitter: Mario Gersberg, Odontit S.A., Buenos Aires Argentina, Phone: +5411-4825-0221.

1. Classification Name and Number: Orthodontic endosseous Implant (DZE) and (OAT).
Common/Usual Name: Orthodontic implant II.
Proprietary Name: JJG Evolution™ Orthodontic Implant System 011.
IV. Registration No .: 9680963
V. Compliance with Performance Standards: No performance standards are applicable, however we followed "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" issued May 12, 2004. The CP titanium used in these implants meets ASTM F - 67 "Specification for Unalloved Titanium for Surgical Implant Applications," and the Titanium Alloy meets ASTM F - 136. "Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical implant Applications.
VI. Description of the Device: This device is an endosseous dental implant consisting of the major component, a root-form, screw type implant with a specialized head, and accessories, designed to facilitate placing and using the implant in orthodontic procedures.. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are described in Quality System documentation.. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head has a 0.7 mm aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The JJG Evolution™ Orthodontic implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.
VII. Labels and Labeling: Draft labels of the JJG Evolution™ system and instructions for use are provided.
VIII. Substantial Equivalence: The JJG Evolution™ system is substantially equivalent to several small implant systems currently on the market. Some of these are: K063770 by Alpha-Bio Tec, K062733 by Dentaurum, K062367 by the Micerium Group, K062156 by Osstem Implant Co., K060062 by Institut Straumann, K050568 by Ortholution Co., K042965 by Dentarum,

XII

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Inc., and K031936 by Osteomed. The implant is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use as predicate devices. intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
The technological characteristics for this product are similar to those of the predicate devices and those currently on the market Thev are screw-type endosseous dental implants with design and manufacturing concepts and materials similar to those of the predicate devices. Like the Jeil Medical Dual Top system, they have a rounded head with a groove around it for the attachment of elastics, chains or coil springs. Like the Straumann Ortho implant, the JJG Evolution™ system implants are made of made of CP titanium, are solid, one-piece, self-tapping implants with a transmucosal neck that has a smoothly machined surface to allow the ready attachment of epithelial tissue. JJG Evolution™ Orthodontic implants are also mark of titanium alloy, but the ELI alloy is even stronger than titanium.
Descriptive information provided shows that the materials from which this device is made are well-established and well understood in the industry and among professional users. The materials (titanium and titanium alloy) are identical to some of the implants, and similar to those of the others made of titanium alloy.
The FDA "Decision-Making Process" chart was used and appears in

Appendix IV.

(End of Summary)

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Descriptive information provided shows that the materials from which this device is made are well-established and well understood in the industry and among professional users. The materials (titanium and titanium alloy) are identical to some of the implants, and similar to those of the others made of titanium alloy.
The FDA "Decision-Making Process" chart was used and appears in Appendix IV.

(End of Summary)

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K072917

510(k) SUMMARY

Submitter: Mario Gersberg, Pres., Odontit S.A., Buenos Aires, Argentina. Phone: +5411-4825-0221

Classification Name and Number: Endosseous Dental Implant (DZE) -
-Common/Usual Name: Implants, endosseous implants.
lil. Proprietary Name: J.J.G. Evolution™ Monoblock Implant system.
IV. Registration No .: 9680963

XI.

V. Compliance with Performance Standards: No performance standards are applicable, however we followed "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" issued May 12, 2004. The CP titanium used in these implants meets ASTM F - 67 "Specification for Unalloyed Titanium for Surgical Implant Applications," and the titanium alloy meets ASTM F - 136, "Standard Specifications for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical implant Applications."
VI. Description of the Device: This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ Monoblock Implant system is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.
VII. Labels and Labeling: Draft labels of the JJG Evolution™ Monoblock Implant system and instructions for use are provided, together with warnings and contra-indications,
VIII. Substantial Equivalence: The JJG Evolution™ Implant system is substantially equivalent to several small implant systems currently on the market. Some of these are:

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1. Zimmer One Piece Implant, Zimmer Dental Inc., K071235,
1. Endosseous Dental Implant System, K070905,
1. Mistral -One Stage Screw-Type Dental Implants, M.I.S. Implants Technologies, Inc., K070022.
1. Zimmer One-Piece Implant, Zimmer Dental Inc., K062281,
1. Fixature Microthread Osseospeed, Astra Tech, Inc., K053384.
1. Straumann Dental Implant System, Institut Straumann AG. K033984.
1. Replace One Piece Implant. Nobel Biocare UAS. Inc., K023952.
1. Odont Hex System, Odontit SA, K961631.
1. Odontit Osseointegrated Implants System, Odontit SA, K-915375.

The J.J.G. Evolution™ Monoblock Implants System is most similar to Zimmer Dental Inc.'s One Piece Implant which received concurrence of substantial equivalence from the Food and Drug Administration premarket notification submissions. K071235, K062281, and the Odontit Hex System (K961631) and Odontit Osseointegrated Implants system, cleared in K915375. Like these products, the J.J.G. Evolution™ Monoblock Implants System devices are manufactured of titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). The excellent biocompatibility and wear characteristics of this metal and alloy have been demonstrated by the long history of their use in surgical and dental prostheses.

Like other predicate devices, (K070905, Southern Implants; K053384. Astra Tech. Inc.; and K023952, Nobel Biocare; the J.J.G. Evolution™ Monoblock Implants are also available in Grade IV titanium (ASTM F-67). Like several of the predicate devices, the J.J.G. Evolution™ Monoblock Implants are post-type, tapered form, with spirals. Like some of them (e.g. K023972, Replace One Piece implant of Nobel BioCare; K011502, K071235, K062281, Zimmer Dental, Inc.,) they are manufactured with the root form treated to roughen it or otherwise hasten osseointegration, a smooth "neck" to hasten tissue attachment, and variously shaped "top" portions to facilitate formation and attachment of prosthetic elements to replace one, or many, teeth.

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use as predicate devices, they are intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained. The device is intended for immediate implantation in extraction sites. The implant may be immediately loaded after implantation where immediate implant stability and appropriate occlusal

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Image /page/7/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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2008

Mr. Mario Gersberg President Odontit S.A. Marcelo T de Alvear 2099 3 Deg A-C1122AAE Buenos Aires ARGENTINA

Rc: K072917

Trade/Device Name: J.J.G Evolution "" Mini-Implant System,
" Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: DZE, OAT Product Code: II Dated: September 20, 2007 Received: October 16, 2007

Dear Mr. Gersberg:

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.

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Page 2 - Mr. Gersberg

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 (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,

Chiu Lin, Ph.D.

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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X. Indications for Use: [Separate Page]

510(k) Number: NA

Device Name: J.J.G. Evolution™ Monoblock Implant System

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumer

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

Repl. p. 9

510(k) Number: K072017

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X Indications for Use.

510(k) Number: (not assigned)

Device Name: JJG Evolution ™ Orthodontic Implant System

Indications for Use:

Prescription Use (Per 21 CFR 801 Subpart D)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------	--

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

510(k) Number: K072617

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Indications for Use.

510(k) Number: (not assigned)

Device Name: J.J.G Evolution ™ Mini-Implant System

Indications for Use:

Support anchors for temporary restorations during the healing and osseointegration process of permanent implants.

Immediate loading temporary abutments for repairing failing tooth and implant supported restorations.

Transitional supports for immediate replacement of missing teeth,

For use in front maxilla where 4 or more implants are splinted together, may be loaded immediately.

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of ODRH, Office of Device Evaluation (ODE) under (Division Sign-Off) 8 Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072917

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.