(385 days)
None
No
The 510(k) summary describes a system of dental implants and associated components, focusing on mechanical properties and surgical placement. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities that would suggest the use of these technologies.
Yes
The device is intended for surgical placement to support crowns, bridges, or overdentures, which are meant to treat edentulous or partially edentulous conditions, thereby restoring function and improving the patient's oral health.
No
This device is a dental implant system used for surgical placement to support dental prostheses, not for diagnosing medical conditions.
No
The device description clearly outlines physical components such as dental implants, abutments, and surgical instruments, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in the mouth to support dental prosthetics. This is a surgical and restorative procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details physical implants, abutments, and surgical instruments. These are all components used in a surgical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a medical device used for surgical implantation and support of dental prosthetics.
N/A
Intended Use / 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.
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.
Product codes
DZE, NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arch
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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.
Key Metrics
Not Found
Predicate Device(s)
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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a way that suggests unity and collaboration. The profiles are black and are set against a white background. Encircling the profiles are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
3
ס״ד
SECTION 5 ... - ... 510(k) Summary (21 ccFR 807.92)
510(k) Number K133362
| 1 | Submission Owner | SGS International Ltd.
Michaeli Shabtai – CEO
Karolyi Istvan Street 1-3.
Budapest, Hungary
H 1047, Hungary
Telephone Number +36-309611579
Facsimile (Fax) Number +36-309611579 |
|-------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Official Correspondent
Contact Person | Sterling Medical Registration
Daniela Levy - Regulatory Consultant
22817 Ventura blvd. #161
Woodland Hills, CA 91364
Phone: 1-213-787-3026
Fax: 1-213-447-5297
Email: Daniela@sterlingmedicalregistration.com |
| 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
Product Code : DZE
Regulation No : 872.3640
Class : II
Panel : Dental
Subsequent Product Code:
Name : Abutment, implant, dental, endosseous
Product Code : NHA
Regulation No : 872.3630 |
| Class | : | II |
| Panel | : | Dental |
4
- 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.
5
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 | |
| 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 |
| 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 | |
| required | The same | |
| Length | 8, 10, 11.5, 13, 16 (13,16 not for 3.2 | |
| 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 |
| 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 | |
| required | same | |
| Indication for use | Used in soft bone and | |
| designed to enable the change | ||
| 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 |
| surface (HA) | ||
| Self tapping | Yes | Yes |
| Characteristic | P7S Integral Groovy Implant | Predicate Implant |
| 510(k) number | TBD | K051719, K112440 |
| Product Name | P7S Conical Groovy | |
| Implant | I7 Integral | |
| Placement Method | Single step. No exposure | |
| 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 |
| 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 | |
| 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 |
| surface (HA) |
12 Substantial Equivalence
6
STERLING
MEDICAL REGISTRATION
4
7
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.
8
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.