SGS DENTAL IMPLANT

K133362 · Sgs International, Ltd. · DZE · Nov 21, 2014 · Dental

Device Facts

• Record ID: K133362
• Device Name: SGS DENTAL IMPLANT
• Applicant: Sgs International, Ltd.
• Product Code: DZE · Dental
• Decision Date: Nov 21, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Story

SGS Dental Implants System comprises one-stage and two-stage endosseous root-form dental implants, abutments, and surgical instruments. Implants are surgically placed into the maxillary or mandibular arch by dental professionals to support prosthetic restorations (crowns, bridges, overdentures). The system utilizes various implant geometries (screw-type, conical, narrow, integral) and abutment types (healing, ball attachment, titanium, zirconium, PEEK). Implants are self-tapping and feature a Calcium Phosphate surface treatment. The device provides a foundation for prosthetic loading; immediate loading is permitted given sufficient primary stability. The system is used in clinical dental settings. Benefits include restoration of oral function and aesthetics for edentulous or partially edentulous patients.

Clinical Evidence

Bench testing only. Evidence includes mechanical fatigue testing (static and cycling) per ISO 14801, biocompatibility evaluation per ISO 7405, and validation of sterilization, cleaning, packaging, and shelf life. Risk assessment confirmed no new safety or effectiveness issues.

Technological Characteristics

Materials: Ti 6Al-4V ELI (ISO 5832-3), PEEK, Zirconium. Surface: Calcium Phosphate (BONIT). Design: Root-form endosseous implants (screw-type, conical, integral). Dimensions: Diameters 2.4mm–6mm; Lengths 8mm–16mm. Connectivity: Internal hexagonal connection. Sterilization: Not specified (standard dental implant processing).

Indications for Use

Indicated for edentulous or partially edentulous patients requiring surgical placement of dental implants in the maxillary or mandibular arch to support crowns, bridges, or overdentures. Specific diameters (3.0 mm) indicated for mandibular/maxillary central and lateral incisors and denture stabilization. 2.4 mm diameter implants indicated for temporary or long-term use for splint stability and fixation of prostheses. PEEK temporary abutments limited to 30 days.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• A.B.Dental Devices ltd (K051719, K112440, K132125)
• M.I.S (K092555, K040807, K103089)
• Alpha Bio Tec (K063364)
• Nobel Active Multi Unit Abutment (K072570)
• DIO Biotite-H Implant Systems (K073070)

Submission Summary (Full Text)

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

November 21,2014

SGS International Ltd. C/O Ms. Daniela Levy Regulatory Consultant Sterling Medical Registration 22817 Ventura Blvd. #161 Woodland Hills, CA 91364

Re: K133362

Trade/Device Name: SGS Dental Implant Systems Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: October 21, 2014 Received: October 24, 2014

Dear Ms. Levy:

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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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 (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/Resourcesfor You/Industry/default.htm. 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 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 yours,

Susan Runno, DDS, mA

Erin I. Keith, M.S 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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## SECTION 4 -

## Indication for Use Statement

510(k) Number (if known): K133362

Device Name:

SGS® Dental Implants System

Indications for Use (Describe)

SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Two Stage Implants: P1, P7, P7N.

One Stage: P7S, P9S.

One Stage & One-Piece 3.0 mm diameter implants: P7S, P9S are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.

One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: P9S permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.

PEEK Temporary Abutments are for 30 days.

Type of Use (Select one or both, as applicable)

!81Prescription Use (Part 21 CFR 801 Subpart D) O Over-The-Counter Use (21 CFR 801 Subpart

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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ס״ד

# SECTION 5 ... - ... 510(k) Summary (21 ccFR 807.92)

# 510(k) Number K133362

| 1 | Submission Owner | SGS International Ltd.<br>Michaeli Shabtai – CEO<br>Karolyi Istvan Street 1-3.<br>Budapest, Hungary<br>H 1047, Hungary<br>Telephone Number [phone]<br>Facsimile (Fax) Number [phone] |
|-------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Official Correspondent<br>Contact Person | Sterling Medical Registration<br>Daniela Levy - Regulatory Consultant<br>22817 Ventura blvd. #161<br>Woodland Hills, CA 91364<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 3 | Submission Date | October 23, 2013 |
| 4 | Device Trade Name | SGS® Dental Implants System |
| 5 | Regulation Description | Root-form Endosseous Dental Implants & Abutments |
| 6 | Classification | Device Name : Implant, endosseous, root-form<br>Product Code : DZE<br>Regulation No : 872.3640<br>Class : II<br>Panel : Dental<br>Subsequent Product Code:<br>Name : Abutment, implant, dental, endosseous<br>Product Code : NHA<br>Regulation No : 872.3630 |
| Class | : | II |
| Panel | : | Dental |

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- 7 Reason for the Premarket Notification Submission : New Device
8 ldentification of Legally Marketed Predicate Devices :

SGS® Dental Implants System is substantially equivalent to A.B.Dental Devices Itd K051719, K112440, K132125; M.I.S, K092555, K040807,K103089; Alpha Bio Tec K063364; Nobel Active Multi Unit Abutment K072570; DIO Biotite-H Implant Systems K073070; in terms of intended use, indication for use, technological characteristics, performance and user interface.

The predicate devices are a Class II medical device.

- Device Description: ഗ
SGS® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system;

P1 - Screw Type Groovy Implant- Diameter 3.2, 3.75,4.2, 5, 6 Length 8, 10,11.5,13,16 P7 - Conical Groovy Implant - Diameter 3.2, 3.75,4.2, 4.5, 5, 6 Length 8, 10,11.5,13,16 (13,16 not for 3.2 dmm).

P7N - Narrow Conical Implant - Diameter 3, 3.2 Length 10, 11.5, 13, 16

P7S - Integral Groovy Implant - Diameter 3, 3.2, 3.75, 4.2, 5, 6 Length, 10, 11.5, 13, 16 P9S - Thin Integral Implant - Diameter 2.4. 3. 3.2 Length 10. 11.5. 13. 16

Abutments System is compromised of Healing Abutments, Overdenture ball attachments, Straight Titanium Abutments, Angulated Titanium Abutments 15,25, Anatomic Straight Titanium Abutments, Anatomic Angular Titanium Abutments, Anatomic Straight Zirconium Abutments, Straight PEEK Abutments, Temporary Abutments, Screw Type Abutments, Screw Type Angular Abutments and Attachments for Overdenture; impression copy system & surgical instruments are also provided.

- 10 Intended use / Indication for Use:
SGS® Dental Implants System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. SGS® Dental Implants System may be immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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# ERLING

### MEDICAL REGISTRATION

Two Stage Implants: P1, P7, P7N.

One Stage: P7S, P9S.

One Stage & One-Piece 3.0 mm diameter implants: P7S, P9S are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.

One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: P9S permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.

PEEK Temporary Abutments are not to exceed 30 days.

- 11 Performance Standards or Special Controls
- ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of . medical devices used in dentistry.
- . ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
- ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for . endosseous dental implants.
- FDA guidance document: Class II Special Controls Guidance Document: Root-form . Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.

| Characteristic | P1 Screw Type Groovy Implant | Predicate Implant |
|----------------------|--------------------------------------------------------------------------------------------|---------------------------------------------|
| 510(k) number | TBD | K112440 |
| Manufacturer | SGS International Ltd. | AB Dental Ltd. |
| Product Name | P1 Screw Type Groovy Implant | I2 Screw Type |
| Placement Method | Dual step surgery. Later exposure<br>required | The same |
| Length | 8, 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16, 18, 20 |
| Available diameters | 3.2, 3.75, 4.2, 5, 6 | 3.25, 3.75, 4.2, 4.5, 5, 6 |
| Integrated abutment | No | No |
| Material | Ti 6Al-4V ELI | Same |
| MEDICAL REGISTRATION | | |
| External surface | Calcium Phosphate | Sandblasted and acid etched<br>surface (HA) |
| Self tapping | Yes | Yes |
| Characteristic | P7 Conical Groovy Implant | Predicate Implant |
| 510(k) number | TBD | K051719, K112440 |
| Manufacturer | SGS International Ltd. | AB Dental Ltd. |
| Product Name | P7 Conical Groovy Implant | I5 Conical |
| Placement Method | Dual step surgery. Later exposure<br>required | The same |
| Length | 8, 10, 11.5, 13, 16 (13,16 not for 3.2<br>dmm) | 8, 10, 11.5, 13, 16 |
| Available diameters | 3.2, 3.75, 4.2, 4.5, 5, 6 | 3, 3.2, 3.75, 4.2, 4.5, 5, 6 |
| Integrated abutment | No | No |
| Material | Ti 6Al-4V ELI | The same |
| External surface | Calcium Phosphate | Sandblasted and acid etched<br>surface (HA) |
| Self tapping | Yes | Yes |
| Characteristic | P7N Narrow Conical Implant | Predicate Implant |
| 510(k) number | TBD | K132125 |
| Manufacturer | SGS International Ltd. | AB Dental Ltd. |
| Product Name | P7N Narrow Conical Implant | I6B Narrow Implant |
| Placement Method | Dual step surgery. Later exposure<br>required | same |
| Indication for use | Used in soft bone and<br>designed to enable the change<br>of direction during implantation | same |
| Length | 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Available diameters | 3, 3.2 | 3, 3.2 |
| Integrated abutment | No | No |
| Material | Ti 6Al-4V ELI | The same |
| External surface | Calcium Phosphate | Sandblasted and acid etched<br>surface (HA) |
| Self tapping | Yes | Yes |
| Characteristic | P7S Integral Groovy Implant | Predicate Implant |
| 510(k) number | TBD | K051719, K112440 |
| Product Name | P7S Conical Groovy<br>Implant | I7 Integral |
| Placement Method | Single step. No exposure<br>required | same |
| Length | 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Available diameters | 3, 3.2, 3.75, 4.2, 5, 6 | 3, 3.2, 3.75, 4.2, 5, 6 |
| Integrated abutment | No | No |
| Material | Ti 6Al-4V ELI | same |
| External surface | Calcium Phosphate | Sandblasted and acid etched<br>surface (HA) |
| Self tapping | Yes | yes |
| Characteristic | P9S One-piece Esthetic Implant | Predicate Implant |
| 510(k) number | TBD | K132125 |
| Manufacturer | SGS International Ltd. | AB Dental Ltd. |
| Product Name | P9S Integral Groovy Implant | I6 Narrow Integral Implant |
| Placement Method | Single step. No exposure<br>required | same |
| Length | 2.4, 3, 3.2 | 2.4, 3, 3.2 |
| Available diameters | 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Integrated abutment | Yes | Yes |
| Material | Ti 6Al-4V ELI | same |
| External surface | Calcium Phosphate | Sandblasted and acid etched<br>surface (HA) |

### 12 Substantial Equivalence

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# STERLING

# MEDICAL REGISTRATION

4

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5

SGS Dental Implants uses BONIT surface treatment - Calcium Phosphate(CaHPO 4 2H20) which is substantially equivalent to DIO Biotite-H Implant Systems K073070.

# Summary of Equivalence:

SGS® Dental Implants System shares similarity to its predicate devices in terms of intended use, indication for use, technological characteristics, performance and user interface.

As demonstrated by the substantial equivalent table, the differences raise no new issues of safety or effectiveness, since SGS® Dental Abutments System shares similarity or very identical to its predicate devices.

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# MEDICAL REGISTRATION

# Non Clinical Testing

Mechanical Testing - SGS® has conducted Fatigue - Static & Cycling tests which comply with ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. The test results have demonstrated the high resistance and high ability with the use of SGS® Dental Implant System. Therefore, SGS® Dental Implants System raises no new issues of safety or effectiveness than the predicate devices. Safety & Effectiveness testing

Safety & Effectiveness testing such as Sterilization. Cleaning validation. Packaging Validation, Shelf Life were used to demonstrate the safety & effectiveness.

Risk Assessment was conducted and has demonstrated no new safety and/or effectiveness issues than the predicate devices.

#### Conclusion:

As verified by clinical and non clinical data, bench testing, mechanical testing, risk assessment and substantial equivalence, SGS® Dental Implant System shares similarity with its predicated devices by term of intended use, raw material and technical design. The fundamental scientific technology of the device is very similar to the referenced predicate devices, thus SGS® Dental Implant System is considered to be substantially equivalent to its predicate devices and raises no new safety and/or effectiveness issues than the predicate devices.