BioHorizons Simple Solutions with Laser-Lok is an abutment system that includes healing abutments for contouring tissue and final restorative abutments for cementing a prositiesis. The abutment system may be used for a single or multiple unit restoration and is compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer Dental ScrewVent and Tapered ScrewVent implants with 3:5mm, 4.5mm and 5.7mm internal hex-connection, mating platform diameters.

Device Description

BioHorizons Simple Solutions with Laser-Lok is an abutment system comprised of machined titanium endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.5mm and 5.7mm with collar heights of 0.8mm, 1.8mm and 2.8mm. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

The devices are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices and ANSI/AAMI/ISO 11137-2 Sterilization of healthcare products - Radiation -- Part 2: Establishing the sterilization dose.

AI/ML Overview

The provided document describes the BioHorizons Simple Solutions with Laser-Lok, an abutment system for dental implants. This 510(k) submission (K100985) focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria for device performance.

Therefore, the information requested in the prompt, which typically applies to medical devices seeking approval based on performance metrics against specific acceptance criteria (often for diagnostic devices or those with quantifiable outcomes), is largely not applicable in the context of this 510(k) for an implant abutment system.

However, I can extract information related to the study that supports the technological characteristics and substantial equivalence claim, which is the closest available data.

Here's the breakdown of what can be found or inferred from the provided text, and what is not available for this type of device submission:

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

Not Applicable / Not Provided: This device is an implant abutment system, which is typically cleared based on substantial equivalence to existing devices, materials, and biomechanical properties, rather than specific performance metrics like sensitivity/specificity for a diagnostic device. The study described focuses on biological response (bone and soft tissue healing) which is a qualitative outcome demonstrating equivalence or superiority to the predicate's biological interaction, not a quantitative performance metric against a pre-defined acceptance criterion.

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

Sample Size: "Each group received nine implants with abutments placed at the time of surgery."
- Since there are four cohorts (Group A, B, C, D), the total number of implants in the study would be (4 cohorts * 9 implants/cohort) = 36 implants.
Data Provenance:
- Country of Origin: Not specified.
- Retrospective or Prospective: "A prospective study was conducted in a canine model..."

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 Provided / Not Applicable: The study was a canine model investigating bone and soft tissue healing. The "ground truth" here would be the biological response observed in the animal tissue, which is typically analyzed by veterinary pathologists or histologists. The document does not specify the number or qualifications of experts involved in the analysis of the canine tissue samples. It references "Nevins et al concluded...", implying an external study or expert opinion was cited.

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

Not Provided / Not Applicable: Adjudication methods like 2+1 or 3+1 are common in reader studies (e.g., for diagnostic imaging devices where human readers interpret results). This was a preclinical in vivo animal study; adjudication in this context refers to the process by which biological samples (e.g., histological slides) are interpreted, which is not detailed.

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: This is entirely Not Applicable. An MRMC study is relevant for diagnostic devices involving human interpretation of clinical cases, often with AI assistance. This submission pertains to a dental implant abutment and involves a preclinical in vivo study, not a human reader study or AI.

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

No: This is entirely Not Applicable. This device is a physical dental implant component, not a software algorithm.

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

Pathology/Histology of Biological Responses: The study evaluated "bone and soft tissue healing patterns." The results described "significant improvement in peri-implant hard and soft tissue healing" and "intense fibroblastic activity to occur on the abutment-grooved surface, resulting in an interlacing complex of connective tissue fibers oriented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration." This indicates that the "ground truth" was derived from histological or pathological analysis of the tissue samples obtained from the canine model.

8. The sample size for the training set

Not Applicable: This was a preclinical in vivo study, not a machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable: As there is no training set, this question is not relevant.

Summary of the Study that Proves (or supports) the Device's Claims:

The device's claims are primarily related to substantial equivalence in design, materials, and intended use, with an added "Laser-Lok" feature for improved biological integration. The study cited supports the effectiveness of this Laser-Lok feature.

Study Description:

Name of Study: A prospective study conducted in a canine model.
Objective: To evaluate bone and soft tissue healing patterns when Laser-Lok microgrooves are applied to dental implant abutments.
Design: The study consisted of four cohorts:
- Group A: Laser-Lok healing abutment on an RBT implant
- Group B: Laser-Lok healing abutment on an RBT implant with a machined area
- Group C: Machined healing abutment on an RBT implant
- Group D: Machined healing abutment on an RBT implant with a machined area
Methodology: Laser-Lok and machined-surface healing abutments were randomly assigned to internal-connection implants that were either fully RBT treated or RBT-treated with a 0.3mm machined collar. Abutments were placed at the time of surgery.
Sample Size: 9 implants per group (total of 36 implants across four groups).
Results (Reported Device Performance): The study demonstrated "significant improvement in peri-implant hard and soft tissue healing on the Laser-Lok healing abutments as compared to traditional machined abutment surfaces." Specifically, it facilitated "intense fibroblastic activity" and the formation of a "physiologic barrier to apical JE migration."
Ground Truth: Histopathological analysis of bone and soft tissue healing patterns in the canine model.

This preclinical study supports the biological benefits of the Laser-Lok feature, contributing to the overall claim of substantial equivalence and safety/effectiveness for the BioHorizons Simple Solutions with Laser-Lok abutment system.

Summary

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KD0988

510(k) Premarket Notification

BioHorizons Simple Solutions with Laser-Lok

510(k) Summary 21 CFR 807.92

Submitter's Name & Address

Manufacturer:	BioHorizons Implant Systems, Inc.
	2300 Riverchase Center
	Birmingham, AL 35244
	Phone (205) 967-7880
	Fax (205) 870-0304
Official contact:	Michael Davis, Regulatory Affairs Specialist
Date prepared:	August 12, 2010

SEP 0 9 2010

Name of the Device

Trade Name:	BioHorizons Simple Solutions with Laser-Lok®
Common or Usual Name:	Dental implant abutment
Classification Name:	Endosseous dental implant abutment
Classification Number:	Class II (21 CFR 872.3630)

Predicate Devices

1. BioHorizons Single-stage Implant System, documented under 510(k) number K073282, concurrence date of February 15, 2008.
1. BioHorizons Internal Implant System, documented under 510(k) number K073268, concurrence date of February 8, 2008.
BioHorizons Tapered Internal Implant System, documented under 510(k) number 3. K071638, concurrence date of October 10, 2007.
1. Zimmer Dental (formerly Sulzer Dental) ScrewVent and Tapered ScrewVent systems, documented under 510(k) number K013227, concurrence date of November 19, 2001.
1. BioHorizons Laser-Lok 3.0 Implant System, documented under K093321, concurrence date of April 2, 2010.

Device Description

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Intended Use

BioHorizons Simple Solutions with Laser-Lok is an abutment system that includes healing abutments for contouring tissue and final restorative abutments for cementing a prosthesis. The abutment system may be used for a single or multiple unit restoration and is compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer Dental ScrewVent and Tapered ScrewVent implants with 3.5mm. 4.5mm and 5.7mm internal hex-connection mating platform diameters.

Compatibility Testing

Compatibility testing was performed on a representative subset of Zimmer ScrewVent and Tapered ScrewVent implants. The subset included the following Zimmer item numbers: TSVB8, TSV4B11, TSV4B13, TSVH13, TSV4H10, TSV4H11, TSV4H16, TSVWH10, TSVWH11, TSVWH13, TSVWH16, TSV6B8, TSV6H8, TSV6H10, TSV6H11 and TSV6H13. This testing verifies compatibility with all Zimmer ScrewVent and Tapered ScrewVent items listed in the following table based on equivalent mating platform geometry.

Platform	Zimmer TaperedScrewVentImplants*	ZimmerScrewVentImplants*	Simple SolutionsHealingAbutments	Simple SolutionsAbutments
3.5mm InternalConnection	TSVBxTSV4BxTSVHxTSV4Hx	SVMBxSVBxSVMHxSVHx	PYHA08LPYHA18LPYHA28L	PY4008L PY5508LPY4018L PY5518LPY4028L PY5528L
4.5mm InternalConnection	TSVWBxTSVWHx	SVWBxSVWHx	PGHA08LPGHA18LPGHA28L	PG4008L PG5508LPG4018L PG5518LPG4028L PG5528L
5.7mm InternalConnection	TSV6BxTSV6Hx	N/A	PBHA08LPBHA18LPBHA28L	PB4008L PB5508LPB4018L PB5518LPB4028L PB5528L

Where variable x = implant length

Technological Characteristics

The fundamental scientific technology of the BioHorizons Simple Solutions with Laser-Lok is substantially equivalent to the existing abutments that are designed to mate with the implant components of the referenced predicate devices. The devices are further processed by applying Laser-Lok to a specified region of the abutment margin.

Laser-Lok is a surface feature in which patterns of micro-machined grooves are applied to the abutment margin, providing a roughened surface to establish a physical, connective tissue attachment (unlike Sharpey fiber attachment). This tissue connection:

1. is functionally oriented,
1. inhibits epithelial cell downgrowth and
1. enables crestal bone attachment adjacent to the implant.

All materials, suppliers, processing, packaging and sterilization methods remain the same as those utilized for the predicate BioHorizons implant systems (K073282, K073268 and K071638), and the Laser-Lok feature is substantially equivalent to that cleared for the BioHorizons Laser-Lok 3.0 Implant System (K093321). The BioHorizons Simple Solutions with Laser-Lok, which is the subject of this 510(k), is substantially

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equivalent to all features of the predicate implant devices which could affect safety or effectiveness because of the similarities in design, materials and intended use.

Summary of Testing

The data presented in this 510(k) submission supports the substantial equivalence of the BioHorizons Simple Solutions with Laser-Lok to the specified predicate devices with respect to performance, safety and effectiveness. A prospective study was conducted in a canine model to evaluate bone and soft tissue healing patterns when Laser-Lok microgrooves are applied to dental implant abutments. The study consisted of four cohorts - Group A: Laser-Lok healing abutment on an RBT implant: Group B: Laser-Lok healing abutment on an RBT implant with a machined area; Group C: Machined healing abutment on an RBT implant; and Group D: Machined healing abutment on an RBT implant with a machined area. Laser-Lok and machined-surface healing abutments were randomly assigned to internal-connection implants that were either fully RBT treated or RBT-treated with a 0.3mm machined collar. Each group received nine implants with abutments placed at the time of surgery. The results demonstrate significant improvement in peri-implant hard and soft tissue healing on the Laser-Lok healing abutments as compared to traditional machined abutment surfaces.

Nevins et al concluded that the presence of the 0.7-mm laser-ablated microchanneled zone consistently enabled intense fibroblastic activity to occur on the abutment-orooved surface, resulting in an interlacing complex of connective tissue fibers onented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Michael Davis Regulatory Affairs Specialist Biohorizons Implant Systems, Incorporated 2300 Riverchase Center Birmingham, Alabama 35244

SEP 0 9 2010

Re: K100985

Trade/Device Name: Bio-Horizons Simple Solutions with Laser-Lok Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 25, 2010 Received: August 30, 2010

Dear Mr. Davis:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Davis

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Runner

Anthony D Watson, B.S., M.S., M.B.A. 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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510(k) Number: K100985

K100985 SEP 0 9 2010

Device Name: BioHorizons Simple Solutions with Laser-Lok®

Indications for Use:

Prescription Use × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suen Runner

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

510(k) Number. K100985

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.)