Salvin Tenting Screw System

K161857 · Salvin Dental Specialties · DZL · Apr 28, 2017 · Dental

Device Facts

• Record ID: K161857
• Device Name: Salvin Tenting Screw System
• Applicant: Salvin Dental Specialties
• Product Code: DZL · Dental
• Decision Date: Apr 28, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone grafts, bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.

Device Story

Salvin Tenting Screw System consists of titanium alloy bone screws and a manual driver; used by dental clinicians in oral surgery settings. Screws are implanted to stabilize bone grafts, bone filling materials, or barrier membranes during bone regeneration procedures in the oral cavity. Device provides mechanical support to maintain space for bone growth. Delivered non-sterile; requires steam sterilization by the user prior to clinical application. Output is the physical fixation of grafting materials, facilitating bone regeneration and improving clinical outcomes for patients requiring oral bone reconstruction.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F543-13, including torsional properties, drive torque, axial pullout, and self-tapping force. Sterilization validation was performed. Results demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F136). Dimensions: 1.5mm diameter; 7mm, 8mm, 9mm lengths. Mechanical fixation via bone screws. Sterilization: Steam. No software or electronic components.

Indications for Use

Indicated for patients requiring bone regeneration in the oral cavity, specifically for the stabilization, fixation, or support of bone grafts, bone filling materials, and barrier membranes.

Regulatory Classification

Identification

An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.

Predicate Devices

• Pro-Fix™ Tenting Screw (K093719)

Reference Devices

• Salvin Dental Fixation Screw System (K073342)

Submission Summary (Full Text)

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Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2017

Salvin Dental Specialties % John Kapitan CEO Kapstone Medical, LLC Po Box 969 Leicester, North Carolina 28748

Re: K161857

Trade/Device Name: Salvin Tenting Screw System Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: March 30, 2017 Received: March 31, 2017

Dear John Kapitan:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - John Kapitan

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory,

> Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 7. Indications for Use Statement

510(k) Number (if known): __ _________________________________________________________________________________________________________________________________________________

Device Name: Salvin Tenting Screw System

Indications for Use:

The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

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# 510(k) Summary

# 1. Applicant

Salvin Dental Specialties, Inc. 3450 Latrobe Drive Charlotte, NC 28211

#### 2. Official Correspondent

Kapstone Medical LLC PO Box 969 Leicester, NC 28748

#### Contact Person:

John Kapitan, CEO Tel: [phone] Fax: [phone] Email: [e-mail]

#### 3. Date Prepared:

March 30, 2017

#### 4. Device Name

| Common/Usual Name: | Tenting Screw System |
|----------------------|-------------------------------------|
| Classification Name: | Intraosseous Fixation Screw or Wire |
| Regulation Number: | 21CFR 872.4880 |
| Product Code: | DZL |
| Classification: | II |
| Panel: | Dental |

#### 5. Predicate Devices

The Salvin Tenting Screw System is substantially equivalent to the Pro-Fix™ Tenting Screw produced by Osteogenics Biomedical. The Pro-Fix™ Tenting Screw is the Primary Predicate and the Salvin Fixation Screw System is a Reference Predicate.

| Predicate | 510(k) Number | Device | Manufacturer |
|-----------|---------------|-------------------------------------|---------------------------|
| Primary | K093719 | Pro-Fix™ Tenting Screw | Osteogenics Biomedical |
| Reference | K073342 | Salvin Dental Fixation Screw System | Salvin Dental Specialties |

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### 6. Description of the Device

The Salvin Tenting Screw System is a set of bone screws and instrumentation. The system consists of a set of screws (one diameter and three lengths) and the driver used to implant these screws. The devices are delivered non-sterile. The screws are made from titanium alloy (Ti-6Al-4V ELI), as described by ASTM F136.

The screws come in one diameter – 1.5mm (5.0mm head diameter), and three lengths – 7mm, 8mm, and 9mm. The screws incorporate a 4mm thread length adjacent to a polished neck.

# 7. Indications for Use

The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone grafts, bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.

# 8. Summary of Technological Similarities and Differences

The Salvin Tenting Screw is substantially equivalent to the primary predicate – the Osteogenics Pro-Fix™ Tenting Screw in terms of material, geometry, and mechanical performance. The Salvin Fixation Screw is a reference predicate with technological similarities in terms of material, geometry, and manufacturing processing.

| Applicant | Salvin Dental | Osteogenics | Salvin Dental |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
| Product Name | Tenting Screw | Pro-Fix™ | Fixation Screw |
| 510(k) Number | K161857 | K093719 | K073342 |
| Product Code | DZL | DZL | HWC |
| Regulation # | 21CFR 872.4880 | 21CFR 872.4880 | 21CFR 888.3040 |
| Class | II | II | II |
| Prescription or O-<br>T-C? | Prescription | Prescription | Prescription |
| Provided Sterile or<br>Non-sterile? | Non-sterile | Non-sterile | Non-sterile |
| Indications for Use | The Salvin Tenting Screw<br>is used to stabilize, fixate,<br>and/or support bone<br>grafts, bone filling<br>materials and /or barrier<br>membranes used for<br>regeneration of bone in<br>the oral cavity. | The Pro-Fix™ Precision<br>Fixation System is used to<br>stabilize, fixate, and/or<br>support bone grafts, bone<br>filling materials and /or<br>barrier membranes used for<br>regeneration of bone in the<br>oral cavity. | The Salvin Fixation<br>Screw is intended for<br>use in internal fixation<br>of small bones including<br>the craniofacial and<br>maxillofacial skeleton<br>affected by trauma, or<br>for reconstruction. |
| Components and<br>Size(s) | Diameter: 1.5mm<br>Lengths: 7, 8, and 9mm | Diameter: 1.5mm<br>Lengths: 7, 8, and 9mm | Diameters: 1.5 and<br>2.0mm<br>Lengths: 4, 6, 8, 10, 13,<br>15, 17mm |

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| Applicant | Salvin Dental | Osteogenics | Salvin Dental |
|------------------------------|-------------------------------------------------------------|--------------------------------|------------------------------------------------------------|
| | SUBJECT DEVICE | PRIMARY PREDICATE | REFERENCE PREDICATE |
| Product Name | Tenting Screw | Pro-Fix™ | Fixation Screw |
| Device/Implant<br>Materials | Ti-6Al-4V ELI per ASTM<br>F136 | Ti-6Al-4V ELI per ASTM<br>F136 | Ti-6Al-4V ELI per ASTM<br>F136 |
| Manufacturing &<br>Cleaning | Proprietary Process<br>Shared with Salvin<br>Fixation Screw | Unknown | Proprietary Process<br>Shared with Salvin<br>Tenting Screw |
| Sterilization<br>Methodology | Steam | Steam | Steam |

# 9. Summary of Performance Data

# Specific Tests Performed:

- · ASTM F543-13
- ଚ୍ଚ Torsional Properties
- > Drive Torque
- ► Axial Pullout
- > Self-Tapping Force
- Sterilization Validation

Bench testing including axial pullout and torque to failure, as well as geometric comparisons of the Salvin Tenting Screw device to the Osteogenics Pro-Fix™ device demonstrated substantial equivalence. The results for Sterile Validation met the acceptance criteria.

#### 10. Conclusion

The Salvin Tenting Screw is substantially equivalent to the Osteogenics Pro-Fix™ predicate device (Primary Predicate - K093719). In addition to conclusions from performance testing and geometric comparisons, the devices have the same "Indications for Use," are available by prescription only, utilize Ti-6Al-4V ELI material, and are provided non-sterile for single-use only. It can be concluded that the Salvin Tenting Screw is substantially equivalent to the predicate device.