The Neo Implants - Neo Implant System are for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neo Implants - Neo Implant System are intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Device Description

Implant fixture: miplant is a threaded, internal abutment connection, root-form titanium dental implant. The Neo implant assortment consists of a number of implants with a diameter of mynant. The Neo miplangths between 7.0 -- 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equiped with interlocking elements for an insertion tool and the non-rotational locking of the abutitient. Supplied sterile.

Temporary part related to the fixture - Cover screw; Made in titanium for implantation. Supplied sterile.

Temporary part related to the fixture - Healing abutment; Made in titanium or PFEK for implantation. Supplied sterile.

Abutments: The Neo Abutment system is a set of modifiable gold alloy or commercially pure titanium abutments (Neolink), which are secured directly to the implant using an abutment screw. For easy wax-up a set of pre-shaped plastic copings can be used to fit to the abutment. Supplied non-sterile.

Prepable Ti abutments: Prepable titanium abutments of straight or angle (20 degrees or less) design made to be adjusted by clinician or dental technician. Crown or bridge cemented on prepped abutment. Supplied non-sterile.

Bar abutment; straight titanium or gold abutment cylinder to which a bar can be bonded (i.e welded or soldered) or cast on to. Supplied non-sterile.

Ball abutment; conventional design (ball head diameter 2,25 mm) used with standard attachments. Supplied non-sterile.

Abutment screw made in gold alloy or titanium. Screw driver connection compatible with screwdrivers supplied by Neoss. Supplied non-sterile.

Round bur; The round bur with diameter Ø1,8-2 with is ISO 1797-1 hand piece connection and shaft.

Twist drills: Two flute twist drill with ISO 1797-1 hand piece connection and shaft. Depth marking corresponding to the implant lengths in the Neoss implant system, hence 7, 9, 11, 13, 15 and 17. Diameter from Ø2.2 to Ø5,1 in appropriate steps to match the Neoss implants.

Screwtap: Screwtap for the different implant diameters existing in the Neo Implant system (Ø3,5 to Ø5,5) with ISO 1797-1 hand piece connection and shaft.

Countersink: Countersink, (05,5) with ISO 1797-1 hand piece connection and shaft. The tool has a centring tap in relation to the prepared hole.

Material of bone cutting instruments is medical grade stainless steel currently being used for similar components.

AI/ML Overview

The provided text describes the Neoss Ltd Neo Implant System and its submission for 510(k) premarket notification. It asserts substantial equivalence to predicate devices but does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.

Instead, the submission relies on the concept of substantial equivalence to existing legally marketed devices. This means that the manufacturer argues their new device is as safe and effective as a predicate device already on the market, rather than conducting a new, comprehensive clinical study to prove performance against pre-defined acceptance criteria.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, ground truth establishment, MRMC study, standalone performance) cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" here implicitly refer to the demonstration of substantial equivalence to predicate devices.
Reported Device Performance: Not reported in terms of clinical outcomes or specific quantitative metrics against acceptance criteria. The performance is implied to be equivalent to the predicate devices.
The document mentions:
- Mechanical Testing: "Mechanical testing requested for Screw-type Endosseous Implants are described in the Guideline 'Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants', dated December 9, 1996."
- Conclusion regarding further testing: "Neo implant and abutment designs are within the scope of the Guideline... why we have come to the conclusion that further testing will not race new issues of safety and efficacy." and "Neo bone cutting instruments, are in terms of design, material, dimensions, and intended us in all relevant aspect identical to predicative devices why we have come to the aonclusion that further testing will not race new issues of safety and efficacy."
This indicates that the manufacturer believes their device meets the expectations of the guideline and is sufficiently similar to predicates that further testing for safety and efficacy to establish new acceptance criteria is not needed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable/Not provided. No clinical test set or data provenance is detailed, as the submission relies on substantial equivalence rather than a new clinical study with a test set.

3. 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/Not provided. No test set requiring expert-established ground truth is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No test set requiring adjudication is mentioned.

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

No MRMC study was done, as this is a dental implant system, not an AI-assisted diagnostic device.

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

Not applicable. This is a medical device (dental implant), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. No new ground truth was established for a performance study. The "ground truth" for the submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

Not applicable/Not provided. This is a medical device, not a machine learning model.

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

Not applicable/Not provided. This is a medical device, not a machine learning model.

In summary: The provided document is a 510(k) summary for a dental implant system. The regulatory pathway of "substantial equivalence" as utilized here means that the manufacturer is demonstrating that their device is as safe and effective as pre-existing, legally marketed predicate devices, rather than conducting new clinical trials to meet specific, quantified acceptance criteria. Therefore, most of the questions pertaining to clinical study design, data sets, expert review, and ground truth are not addressed in this type of submission.

Summary

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K04 3195

SECTION 2.

MAR 7 - 2005

A. 510(k) SUMMARY

Summary of Safety and Effectiveness

In accordance with 21 CFR 807.92, the following information constitutes the Neoss Ltd summary for the Neo Implant System.

SUBMITTER'S NAME:	Neoss Ltd
ADDRESS:	Windsor House
	Cornwall Road
	Harrogate, HG1 2PW, UK
CONTACT PERSON:	Fredrik Engman
TELEPHONE NUMBER:	+44 (0) 1423 817733 , +46 (0)709 792 892
FAX NUMBER:	+44(0) 1423 817744
E-MAIL	fredrik@neossimplant.com
DATE OF SUBMISSION:	Nov 5, 2004

Identification of device 1.

Classification name:	Implant endosseous root-form
Proprietary Name:	Neo Implant System
Common Name:	Dental implant, Dental abutment, Abutment screwRound bur, Twist drill, Countersink and Screwtap
Classification Status:	Class II per regulations 872.3640
Product Codes:	DZE

2. Equivalent devices

Neoss Ltd believes the Neo Implant is substantially equivalent to the following implant fixtures including temporary parts (cover screw and healing abutment);

Astra Tech Implants Dental System- Immediate function, nr K041492 ﺳ
and the following abutments:
Astra Tech Implants- Dental system, nr K931767 (Neo Titanium, Neo gold, ball, bar, abutment screw)
Astra Tech implant- Dental System Additional components, nr K974738. (Ti prepable abutments).

Neoss Ltd also believes the bone cutting instruments are substantially equivalent to the following implant fixtures;

3i single use, disposable drills, taps, burs etc. - nr K962014 (non-sterile reusable components)

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KC-4765

Description of the Device 3.

Implant fixture:

miplant is a threaded, internal abutment connection, root-form titanium dental implant. The Neo implant assortment consists of a number of implants with a diameter of mynant. The Neo miplangths between 7.0 -- 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equiped with interlocking elements for an insertion tool and the non-rotational locking of the abutitient. Supplied sterile.

Temporary part related to the fixture - Cover screw; Made in titanium for implantation. Supplied sterile.

Temporary part related to the fixture - Healing abutment; Made in titanium or PFEK for implantation. Supplied sterile.

Abutments:

The Neo Abutment system is a set of modifiable gold alloy or commercially pure titanium abutments (Neolink), which are secured directly to the implant using an abutment screw. For easy wax-up a set of pre-shaped plastic copings can be used to fit to the abutment. Supplied non-sterile.

Bar abutment; straight titanium or gold abutment cylinder to which a bar can be bonded (i.e welded or soldered) or cast on to. Supplied non-sterile.

Ball abutment; conventional design (ball head diameter 2,25 mm) used with standard attachments. Supplied non-sterile.

Abutment screw made in gold alloy or titanium. Screw driver connection compatible with screwdrivers supplied by Neoss. Supplied non-sterile.

Round bur;

The round bur with diameter Ø1,8-2 with is ISO 1797-1 hand piece connection and shaft.

Twist drills:

Two flute twist drill with ISO 1797-1 hand piece connection and shaft. Depth marking corresponding to the implant lengths in the Neoss implant system, hence 7, 9, 11, 13, 15 and 17. Diameter from Ø2.2 to Ø5,1 in appropriate steps to match the Neoss implants.

Screwtap:

Screwtap for the different implant diameters existing in the Neo Implant system (Ø3,5 to Ø5,5) with ISO 1797-1 hand piece connection and shaft.

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Countersink:

Countersink, (05,5) with ISO 1797-1 hand piece connection and shaft. The tool has a centring tap in relation to the prepared hole.

Material of bone cutting instruments is medical grade stainless steel currently being used for similar components.

Intended use 4.

The Neo Implant is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices, which can restore chewing function, speech and aesthetic appearance. This is accomplished using a single-stage and two-stage surgical procedure and cement or screw retained restorations.

The Neo Implants - Neo Implant System are intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Neo Abutments includes a set of components that are intended to function on Neo implants or compatible external hex. Replace Select implants and Straumann implants, as a base prosthetic construction.

Surgical drills, screwtaps, countersinks or burs are used in dental, oral/maxiofacial surgery for preparing the bone (osteotomy), to receive Neo implant(s) for restorative reconstruction.

Technological characteristics, comparison to predicate device. 5.

Substantial equivalence of the Neo Implant System is based on design similarities between the predicative device and the devices in this application, since the devices are very similar in terms of material, size and basic design.

Like the prodicate devices, the bone cutting instruments are intended to prepare the surgical site and the technique is identical to predicative devices in relation to handpiece connection and rotational specd. The material is stainless steel with machined electro polished surface with laser depth and type marking. The basic design is the same with twist drill design for the drills, countersink with centring tap and a screwtap with adjusted thread profile in relation to the Neo Implants.

6. Discussion of performance testing.

Mechanical testing requested for Screw-type Endosseous Implants are described in the Guideline "Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants", dated December 9, 1996.

Neo implant and abutment designs are within the scope of the Guideline "Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants", dated December 9, 1996, in terms of material, dimensions, and intended use why we have come to the conclusion that further testing will not race new issues of safety and efficacy.

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Neo bone cutting instruments, are in terms of design, material, dimensions, and intended us in all relevant aspect identical to predicative devices why we have come to the aonclusion that further testing will not race new issues of safety and efficacy.

Please see section 5. Part B Performance Testing.

7. Conclusion

Based on comparison, the Neo Implants System including bone cutting instruments, from Neoss Ltd, is substantially equivalent to the predicate devices.

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

MAR 7 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NEOSS Limited C/O Dr. Russell P. Pagano Vice President M Squared Associates, Incorporated 719 A Street, NE Washington, DC 20002

Re: K043195

Trade/Device Name: Neo Implant System Regulation Number: 872.3640 Regulation Namc: Endosscous Implant Regulatory Class: II Product Code: DZE Dated: February 24, 2005 Received: February 28, 2005

Dear Dr. Pagano:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becares is ned 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 mensiale commerce prior to frid , as , as , ac, accordance with the provisions of Amendinens, or to devrees that have e Act (Act) that do not require approval of a premarket the rederal I ood, Drug, und Commens , therefore, market the device, subject to the general approval appliednon (the Act. The general controls provisions of the Act include controls provisions of aregistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III If your device is classified (osuch additional controls. Existing major regulations affecting (FMA), it may of subject to bash adata and the end Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Lederal Register.

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Page 2 - Dr. Pagano

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S Issualled of a substantial vith other requirements
mean that FDA has made a determination that your device that hearther Federal assession mean that FDA has made a decemmanen that Journalisms administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by other Federal of the Act or any rederal statues and regulations, but not limited to: registration in mostical You must comply with an the Acc S requirements) in CFR Part 801); good manufacturing practice and listing (21 CFR Pat 607), laboling (21 CFR Pat 820), and if requirements as set form in the quality bjokens (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 5 10(k) I his letter will anow you to begin maileding of substantial equivalence of your device to a premarket nothleadon. The PDF mailing or 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), a If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation
15 (240) 276-0116 at 12:40) 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 may obtain other general miormation on consumer Assistance at its toll-free Division (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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B. INDICATIONS FOR USE

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: Neo Implant System

Indications for Use:

The Neo Implants - Neo Implant System arc for single-stage and two-stage surgical The Neo implaine ment or screw retained restorations.

procedures and centent of screw reasing are intended for immediate placement and The Neo Implants - Neo Implane 5 Joical and Stations recognizing sufficient bone function on single tooth and rol many of munding, to restore chewing function. Multiple tooth applications may be splinted with a bar.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

ાર

Over the Counter Use

Susan Rios

Trilogy General Hospital,
Lawn Center, Dental Devices

Number
8041395

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.