(379 days)
No
The 510(k) summary describes a system of dental implants and related components, which are physical devices. There is no mention of software, algorithms, image processing, or any terms related to AI or ML in the intended use, device description, or performance studies.
Yes.
The device is described as "SGS® Dental Implants System," which is intended for surgical placement to support crowns, bridges, or overdentures. These are restorative procedures that aim to treat the loss of teeth, thus serving a therapeutic purpose by restoring function and aesthetics.
No
The device description clearly states it is a dental implant system intended for surgical placement to support crowns, bridges, or overdentures, which are restorative and prosthetic functions, not diagnostic ones.
No
The device description clearly outlines physical components such as dental implants, cover screws, healing caps, and abutment systems, which are hardware.
Based on the provided information, the SGS® Dental Implants System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical placement in the mouth to support dental prosthetics. This is a direct medical intervention on a patient's body.
- Device Description: The description details physical implants and abutments, which are surgically implanted components.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. Dental implants are surgically placed within the body for structural support.
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. Narrow diameter implants (3.2) are intended for maxillary lateral incisors and mandibular lateral and central incisors.
Two Stage Implants: P7N, P1D, P5D, P7D.
PEEK Temporary Abutments are not to exceed 30 days.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
SGS® Dental Implants System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems;
Dental Implants:
P7N Narrow Conical Implant, Internal Hex available as follow:
Diameter 3.2 mm Length 8 mm
P1D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 5, 6 mm Length 8, 10, 11.5, 13, 16.
P5D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.
P7D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.
Dental Abutments consist of:
Healing Abutments, Anatomic Straight Abutments, Straight Abutments, Straight Abutments Narrow/Wide, PEEK Temporary Abutments for bars, Angular Anatomic Abutments Ti, Angular Abutments Slim/Narrow, Multi-Base Angular Abutment, Anqular Ball Attachment, S-lock Straight/Anqular Abutment, Easy-Fix Angular Abutment, Straight/One-piece angular Multi-unit Abutment, Ball Attachments, Abutment for temporary restoration, Easy Fix Abutments Straight/Angular, Smart Lock abutments Straight/Angular, Flat connection abutments for casting, overdenture attachments. Titanium abutments are CNC machined with no anodized surface.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Clinical Testing - No clinical data is included in this submission.
Sterilization Validation Test was carried out with SGS to ISO 11137 - Test results have demonstrated that the SAL of 10-® was achieved and all testing requirements were met.
Shelf Life Test was carried out with accordance to ASTM F-1980 in order to validate the claimed shelf life of 5 years.
Steam Sterilization Test was carried out with accordance to ISO 17665 - Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met.
Biocompatibility - SGS Dental Implants are made of Ti6Al4V ELI using the conventional manufacturing process. Biocompatibility testing per the FDA Guidance Use of ISO 10993-1 was leveraged from the Primary Predicate.
Fatigue test were carried out with accordance to ISO 14801 in order to verify the mechanical connection strength of implant/abutment, results have demonstrated the performance with the use of SGS® Dental Implants / Abutments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2019
SGS International Ltd % Daniela Levy Regulatory Consultant Sterling Medical Registration 22815 Ventura Blvd Woodland Hills, California 91364
Re: K182219
Trade/Device Name: SGS® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 10, 2019 Received: July 31, 2019
Dear Daniela 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image contains the logo for SGS Dental. The logo features an orange square with rounded corners on the left side, containing a stylized white graphic that resembles a series of curved lines. To the right of the square, the letters "SGS" are written in a bold, black sans-serif font. Below "SGS", the word "Dental" is written in a smaller, orange sans-serif font.
Indication for Use Statement
510(k) Number (if known):
K182219
Device Name:
SGS® Dental Implants System
Indications for Use (Describe)
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. Narrow diameter implants (3.2) are intended for maxillary lateral incisors and mandibular lateral and central incisors.
Two Stage Implants: P7N, P1D, P5D, P7D
PEEK Temporary Abutments are not to exceed 30 days.
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D) □ 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)
T"D
3
Image /page/3/Picture/0 description: The image contains the logo for SGS Dental. The logo features an orange square with rounded corners on the left side, containing a white, stylized image of a spiral or helix. To the right of the square, the text "SGS" is written in a bold, sans-serif font, with the word "Dental" appearing below it in a smaller, orange font.
510(k) Summary (21 CFR 807.92)
510(k) Number K182219
- Type of Submission Premarket Notification (21 CFR 807.90(e)) 510(k) Traditional 1
| 2 | 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 | |||||
| 3 | Official Correspondent | ||||
| Contact Person | Sterling Medical Registration | ||||
| Daniela Levy - Regulatory Consultant | |||||
| 22815 Ventura blvd. | |||||
| Woodland Hills, CA 91364 | |||||
| Phone: 1-213-787-3027 | |||||
| Email: sterlingmedical2017@gmail.com | |||||
| 4 | Prepared Date | August 28, 2019 | |||
| 5 | Device Trade Name | SGS® Dental Implants System | |||
| 6 | Regulation Description | Endosseous Dental Implants Abutment | |||
| 7 | Classification | Product Code: | DZE | ||
| Device Name | : | Implant, endosseous, root-form | |||
| Regulation No | : | 872.3640 | |||
| Class | : | II | |||
| Panel | : | Dental | |||
| Secondary Product Code: | NHA | ||||
| 8 | Reason for the Premarket Notification Submission | : | New Device | ||
| 9 | Identification of Legally Marketed Predicate Devices | : |
- Primary Predicate:
SGS International Ltd K133362;
4
Image /page/4/Picture/0 description: The image contains the logo for SGS Dental. The logo features an orange square with rounded corners on the left side, containing a white abstract design resembling a series of curved lines. To the right of the square, the text "SGS" is displayed in bold, black letters, with the word "Dental" underneath in a smaller, orange font. The overall design is clean and professional, suggesting a company in the dental industry.
eference Devices: UNIQA Dental Itd K180598; A.B.Dental Devices K112440; Osstem lmplant Co Ltd K182091;
in terms of intended use, indication for use, raw material, technological characteristics and performance. The primary predicate and referenced devices are Class II medical devices.
10 Device Description:
SGS® Dental Implants System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems; Dental Implants:
P7N Narrow Conical Implant, Internal Hex available as follow:
Diameter 3.2 mm Length 8 mm
P1D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 5, 6 mm Length 8, 10, 11.5, 13, 16.
P5D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.
P7D Conical Groovy Double Connection Implant, Internal hex Conical Connection available as follow:
Diameter 3.5, 3.75, 4.2, 4.5, 5, 6 mm Length 8, 10, 11.5, 13, 16.
Dental Abutments consist of:
Healing Abutments, Anatomic Straight Abutments, Straight Abutments, Straight Abutments Narrow/Wide, PEEK Temporary Abutments for bars, Angular Anatomic Abutments Ti, Angular Abutments Slim/Narrow, Multi-Base Angular Abutment, Anqular Ball Attachment, S-lock Straight/Anqular Abutment, Easy-Fix Angular Abutment, Straight/One-piece angular Multi-unit Abutment, Ball Attachments, Abutment for temporary restoration, Easy Fix Abutments Straight/Angular, Smart Lock abutments Straight/Angular, Flat connection abutments for casting, overdenture attachments. Titanium abutments are CNC machined with no anodized surface.
5
Image /page/5/Picture/0 description: The image contains the logo for SGS Dental. The logo consists of an orange square with rounded corners on the left side, containing a white abstract design of curved lines. To the right of the square are the letters "SGS" in black, with the word "Dental" in orange underneath. The logo is simple and modern, with a clean design.
11 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. Narrow diameter implants (3.2) are intended for maxillary lateral incisors and mandibular lateral and central incisors.
Two Stage Implants: P7N, P1D, P5D, P7D.
PEEK Temporary Abutments are not to exceed 30 days.
- 12 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.
- . ISO 11137-1:2006 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- . ISO 11737-2: 2009 Sterilization of medical devices -- Microbiological methods --Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- . ASTM F-1980 - 16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: . Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in . vitro cytotoxicity
6
Image /page/6/Picture/0 description: The image contains the logo for SGS Dental. The logo features an orange square with rounded corners on the left side, containing a series of white curved lines resembling a stylized globe or tooth shape. To the right of the graphic is the text "SGS" in bold black letters, with the word "Dental" underneath in a smaller, orange font.
- FDA guidance document: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
- Chemical and SEM analysis performed on implants per Class II Special Controls . Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.
- Endotoxin batch testing protocol per FDA Guidance Document Submission and . Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
7
Image /page/7/Picture/0 description: The image contains the logo for SGS Dental. The logo consists of an orange graphic on the left, which features a series of curved lines that resemble a spiral or a stylized representation of teeth. To the right of the graphic, the text "SGS" is displayed in a bold, sans-serif font, with the word "Dental" appearing below it in a smaller, slightly different font, also in orange.
13 Substantial Equivalence
SE Table - Indication for Use:
| Candidate | Primary Predicate | Reference Device | |
|---|---|---|---|
| SGS International | SGS International | UNIQA Dental Itd | |
| K Number | K182219 | K133362 | K180598 |
| 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. | |||
| Narrow diameter implants | |||
| (3.2) are intended for | |||
| maxillary lateral incisors and | |||
| mandibular lateral and central | |||
| incisors. | |||
| Two Stage Implants: P7N, | |||
| P1D, P5D, P7D. PEEK | |||
| Temporary Abutments are | |||
| not to exceed 30 days. | 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, and | |||
| protection of graft sites. | |||
| PEEK Temporary Abutments | |||
| are not to exceed 30 days. | UNIQA Dental ® Dental | ||
| Implants System is indicated | |||
| for use in surgical and | |||
| restorative applications for | |||
| placement in the bone of the | |||
| upper or lower jaw to provide | |||
| support for prosthetic devices, | |||
| such as artificial teeth, in order | |||
| to restore the patient's chewing | |||
| function. UNIQA Dental ® | |||
| Dental Implants System is | |||
| indicated also for immediate | |||
| loading when good primary | |||
| stability is achieved and with | |||
| appropriate occlusal loading. | |||
| UNIQA Conical Connection | |||
| Implants: #UCI & #UC7 are to | |||
| be used only with straight | |||
| abutments. | |||
| Conical Mini implants | |||
| (Ø3.3mm) are indicated for use | |||
| in surgical and restorative | |||
| applications for placement only | |||
| in the mandibular central, | |||
| lateral incisor and maxillary | |||
| lateral incisor regions of | |||
| partially edentulous jaws, to | |||
| provide support for prosthetic | |||
| devices such as artificial teeth, | |||
| in order to restore the patient' | |||
| chewing function. Mandibular | |||
| central and lateral incisors | |||
| must be splinted if using two or | |||
| more narrow implants adjacent | |||
| to one another. | |||
| Reference Device | Reference Device | Reference Device | |
| Osstem Implant Co Ltd | A.B. Dental Devices | ||
| K Number | K182091 | K112440 | |
| Indication for | |||
| use | Osstem Abutment System is | ||
| intended for use with a dental | |||
| implant to provide support for | |||
| prosthetic restorations such | |||
| as crowns, bridges, or | |||
| overdentures. | The AB Dental Devices | ||
| implants are intended for | |||
| surgical placement in the | |||
| maxillary and/or mandibular | |||
| arch to support crowns, | |||
| bridges, or overdentures in | |||
| edentulous or partially | |||
| edentulous patients. I7 Integral | |||
| implant, I5 Conical implant, | |||
| P15 Temporary abutment. |
.
8
Image /page/8/Picture/0 description: The image contains the logo for SGS Dental. The logo consists of an orange square with rounded corners on the right side. Inside the square are white curved lines. To the right of the square is the text "SGS" in black, with the word "Dental" in orange below it.
| P12-T,L Temporary flat connection abutment, and P16 adaptor are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | |
|---|---|
| -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
9
Image /page/9/Picture/0 description: The image is a logo for SGS Dental. The logo consists of an orange square with rounded corners on the left side, and the text "SGS Dental" on the right side. The orange square contains a white design that looks like a stylized tooth or a series of curved lines. The text "SGS" is in black, and the text "Dental" is in orange.
SE - Dental Implants
| Characteristic | Candidate
P7N Narrow Conical Implant | Primary Predicate
P7 Conical Groovy Implant |
|-------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K133362 |
| Manufacturer | SGS International Ltd. | SGS International Ltd. |
| Product Name | P7N Narrow Conical Implant | P7 Conical Groovy Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread |
| Measurements
Ø / Length mm | 3.2Ø: 8 | 3.2Ø: 8, 10, 11.5
3.75Ø: 8, 10, 11.5, 13, 16
4.2Ø: 8, 10, 11.5, 13, 16
4.5Ø: 8, 10, 11.5, 13, 16
5.0Ø: 8, 10, 11.5, 13, 16
6.0Ø: 8, 10, 11.5, 13, 16 |
| Connection Type | Internal Hex | Internal Hex |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Surface
Treatment | Calcium Phosphate | Calcium Phosphate |
| Self tapping | Yes | Yes |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
| Characteristic | Candidate
P1D Conical Groovy Double
Connection Implant | Primary Predicate
P1 Screw Type Groovy Implant |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K133362 |
| Manufacturer | SGS International Ltd. | SGS International Ltd. |
| Product Name | P1D Conical Groovy Double
Connection Implant | P1 Screw Type Groovy Implant |
| Thread Design | Straight | Tapered, Double Thread |
| Measurements
Ø / Length mm | 3.5Ø: 8, 10, 11.5, 13, 16
3.75Ø: 8, 10, 11.5, 13, 16
4.2Ø: 8, 10, 11.5, 13, 16
5Ø: 8, 10, 11.5, 13, 16
6Ø: 8, 10, 11.5, 13, 16 | 3.2Ø: 8, 10, 11.5
3.75Ø: 8, 10, 11.5, 13, 16
4.2Ø: 8, 10, 11.5, 13, 16
4.5Ø: 8, 10, 11.5, 13, 16
5Ø: 8, 10, 11.5, 13, 16
6Ø: 8, 10, 11.5, 13, 16 |
| Connection Type | Internal conical | Internal Hex |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Surface
Treatment | Calcium Phosphate | Calcium Phosphate |
| Self tapping | Yes | Yes |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
10
Image /page/10/Picture/0 description: The image contains the logo for SGS Dental. The logo features a rounded square shape with an orange background and a series of white, curved lines resembling a spine or vertebrae. To the right of the graphic is the text "SGS" in bold, black letters, with the word "Dental" underneath in a smaller, orange font.
| Characteristic | Candidate
P5D Conical Groovy Double
Connection Implant | Primary Predicate
P7 Conical Groovy Implant |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K133362 |
| Manufacturer | SGS International Ltd. | SGS International Ltd. |
| Product Name | P5D Conical Groovy Double Connection
Implant | P7 Conical Groovy Implant |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread |
| Measurements
Ø / Length mm | 3.50Ø: 8, 10, 11.5, 13, 16
3.75Ø: 8, 10, 11.5, 13, 16
4.20Ø: 8, 10, 11.5, 13, 16
4.50Ø: 8, 10, 11.5, 13, 16
5.00Ø: 8, 10, 11.5, 13, 16
6.00Ø: 8, 10, 11.5, 13, 16 | 3.20Ø: 8, 10, 11.5
3.75Ø: 8, 10, 11.5, 13, 16
4.20Ø: 8, 10, 11.5, 13, 16
4.50Ø: 8, 10, 11.5, 13, 16
5.00Ø: 8, 10, 11.5, 13, 16
6.00Ø: 8, 10, 11.5, 13, 16 |
| Connection Type | Internal conical | Internal Hex |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI |
| Surface
Treatment | Calcium Phosphate | Calcium Phosphate |
| Self tapping | Yes | Yes |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
| Characteristic | Candidate
P7D - Dental Implant with Double
Connection | Primary Predicate
P7 Conical Groovy Implant | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K133362 | |
| Manufacturer | SGS International Ltd. | SGS International Ltd. | |
| Product Name | P7D - Dental Implant with Double
Connection | P7 Conical Groovy Implant | |
| Thread Design | Tapered, Double Thread | Tapered, Double Thread | |
| Measurements
Ø / Length mm | 3.50 Ø: 8, 10, 11.5, 13, 16
3.75Ø: 8, 10, 11.5, 13, 16
4.20 Ø: 8, 10, 11.5, 13, 16
4.5Ø: 8, 10, 11.5, 13, 16
5.00 Ø: 8, 10, 11.5, 13, 16
6.00 Ø: 8, 10, 11.5, 13, 16 | 3.20 Ø: 8, 10, 11.5
3.75Ø:8, 10, 11.5, 13, 16
4.20 Ø: 8, 10, 11.5, 13, 16
4.5Ø: 8, 10, 11.5, 13, 16
5.00 Ø: 8, 10, 11.5, 13, 16
6.00 Ø: 8, 10, 11.5, 13, 16 | |
| Connection Type | Internal conical | Internal Hex | |
| Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI | |
| Surface
Treatment | Calcium Phosphate | Calcium Phosphate | |
| Self tapping | Yes | Yes | |
| Sterilization | Gamma Ray | Gamma Ray | |
| Packaging | Double packaging | Double packaging | |
| | Candidate | Primary Predicate | Reference Device |
| | SGS International | SGS International | UNIQA Dental Itd |
| K Number | | K133362 | K180598 |
| Product Name | Healing Abutments
(HD,HND,HW7D,HW8D,H
WD) | Healing Abutments
(HN,HNN,HWN,H,HN, HW) | Healing Cap # UOHX |
| Dimensions | Narrow, Length: wide 2,3,4;
Normal, Length: 2,3,4,5,6
Wide, Length: 3,5 | Narrow, Length: 2,3,4
Normal, Length: 2,3,4,5,6
Wide, Length: 3,5 | Diameter: Mini (#UOHM) -
Diameter 4.0, 4.5 Heights 3,
4, 5,7
Regular (#UOHR) -
Diameter 4.0, 4.5, 5.0, 6.0,
7.0 Heights 3, 4, 5, 7 |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal conical | Internal Hex | Internal conical |
| | | | |
| | Candidate | Primary Predicate | Reference Device |
| | SGS International | SGS International | UNIQA Dental Itd |
| K Number | | K133362 | K180598 |
| Product Name | Anatomic Straight Titanium
Abutment S1AD | Anatomic Straight Titanium
Abutment S1A, S1AN | Transfer Abutment #UOTX |
| Dimensions | Normal Profile: Height 1, 2,
3 mm | Narrow: Straight Anatomic
Abutment-Profile Height 1
mm
Normal: Profile Height 1, 2, 3
mm | Mini Diameter: 4.5 mm,
Height 1, 2, 3, 4, 5 mm
Lengths: 5.5, 7 mm (#UOTM)
Regular Diameter: 4.5, 5.0,
6.0 mm, Height 1, 2, 3, 4, 5
mm, Lengths: 4.0(not for 4.5),
5.5, 7 mm(#UOTR)
Provided with: Screw Mini
Conical (#UOSM-0001);
Screw Regular Conical
(#UOSR-0001) |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Conical | Internal Hex | Internal Conical |
| | | | |
| | Candidate | Primary Predicate | Reference Device |
| | SGS International | SGS International | UNIQA Dental Itd |
| K Number | | K133362 | K180598 |
| Product Name | Straight Titanium Abutment
S1WN,S1D, S1ND, S1WD,
S1W, S1W8D, S1W8 | Straight Titanium Abutment
S1N,S1WN, S1,S1N,S1W | Transfer Abutment #UOTX |
| Dimensions | Narrow: Wide - Length:9
Normal: Length: 7, 9, 12, 15
Narrow: Length: 7, 9
Wide: Length:9, 12
S1W8D, S1W8 - 8mm wide
with 10mm length | Narrow: Narrow, Wide -
Length:9
Normal: Length: 5, 7, 9, 12, 15
Narrow: Length: 7, 9
Wide: Length:9 | Mini Diameter: 4.5 mm,
Height 1, 2, 3, 4, 5 mm
Lengths: 5.5, 7 mm (#UOTM)
Regular Diameter: 4.5, 5.0,
6.0 mm, Height 1, 2, 3, 4, 5
mm, Lengths: 4.0(not for 4.5), |
| | | | 5.5, 7 mm(#UOTR)
Provided with: Screw Mini
Conical (#UOSM-0001) ;
Screw Regular Conical
(#UOSR-0001 |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal conical | Internal Hex | Internal conical |
| | Candidate | Primary Predicate | Reference Device |
| | SGS International | SGS International | |
| Product Name | Anatomic Straight PEEK
Abutment S1AN-PEEK | Anatomic Straight PEEK
Abutment S1A-PEEK | |
| K Number | | K133362 | |
| Dimensions | Diameter: 3.0, Profile:1 | Diameter: 3.75
Profile:1,2,3 | |
| Material | PEEK-CLASSIX | PEEK-CLASSIX | |
| Connection | Internal Hex | Internal Hex | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | A.B. Dental Devices | |
| K Number | | K112440 | |
| Product Name | Abutment for bars S1T,
S1TD , S1TN | P7 Anti rotation aesthetic
abutment | |
| Dimensions | Diameter:3.75
Height: 0.5, 1.5, 2.5, 3.5;
NP : 3.0 dmm, Height: 0.5,
1.5, 2.5 | Diameter:3.75
Height: 1, 2, 3; | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal Hex/conical | Internal Hex | |
| | Candidate | Reference Device | Reference Device |
| | SGS International | UNIQA Dental Itd | |
| K Number | | K180598 | |
| Product Name | Angular Abutments S2D-29 | Angled Multi Unit Abutment,
MUA, D-type #UAMD | |
| Dimensions | Diameter: 3.75, Length: 11 | Diameter:3.75, regular
platform
Height: 1, 2, 3 | |
| Angulations | 29° | 17°, 30° | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal conical | Internal Hex/ | |
| | Candidate | Primary Predicate | Reference Device |
| | SGS International | SGS International Itd | UNIQA Dental Itd |
| K Number | | K133362 | K180598 |
| Product Name | Angular Abutments S2D,
S2S, S2DS | Anatomic Angular Titanium
Abutment S2A | UABR Angled Abutment |
| Dimensions | NP Diameter: 3.75, Length:
11
Slim Diameter: 3.75, Length:
11 | Normal: Height 1,2, 3 Length
9, 11 | Diameter: Regular; Length
9,12 - Angle 15, 25 |
| Angulations | 15°, 25° | 15°, 25° | 10°, 15°, 25° |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal conical | Internal Hex | Internal |
| | | | |
| | Candidate | Primary Predicate | Reference Device |
| | SGS International | SGS International | UNIQA Dental Itd |
| K Number | | K133362 | K180598 |
| Product Name | Angular Titanium
Abutment,S2N, S2AN,
S2AD,S2LD | Angular Titanium
Abutment,S2N,S2L, S2A | UAAR Angled Anatomic
abutment |
| Dimensions | Narrow: Angle 25° - length 9
mm
Narrow Anatomic: Angle
15°,25° - Height 1,2 mm
Regular Anatomic: 3.75mm,
Angle 15°,25° - Height
1,2,3,4
Regular: 3.75mm, Length
13mm, Angle 15°,25° - | Narrow: Angle 15°, - length 9
mm
Normal: Angle 15°, 25°-
Length 9, 11 mm
Normal: Height 1,2, 3 Length
9, 11 | Diameter: Regular Profile
Height 1,2,3,4 - Angle 15
Height 1,2,3,4 - Angle 25 |
| Angulations | 15°, 25° | 15°, 25° | 15°, 25° |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex/conical | Internal Hex | Internal |
| | | | |
| | Candidate | Reference Device | Reference Device |
| | SGS International | UNIQA Dental Itd | |
| K Number | | K180598 | |
| Product Name | Multi-Base Angular
Abutment S7 | Angled Multi Unit Abutment,
MUA, D-type #UAMD | |
| Dimensions | Diameter:3.75
Height: 1, 2, 3 | Diameter:3.75, regular
platform
Height: 1, 2, 3 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Angle | 30° | 17°, 30° | |
| Connection | Internal Hex | Internal Hex | |
| | | | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | Osstem Implant Co Ltd | |
| K Number | | K182091 | |
| Product Name | S3-S7 - Angular Ball
Attachment | Port Angled Abutment&
Port Angled Abutment Head | |
| Dimensions | Diameter:3.75
Height: 1, 2, 3 | Diameter:4.63-4.82
Height: 1, 3 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Angle | 17°, 30° | 10°,17°, 30° | |
| Connection | Internal Hex | Internal Hex | |
| | | | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | UNIQA Dental Itd | |
| K Number | | K180598 | |
| Product Name | S4-S7 - Angular Abutments
for immediate loading | Angled Multi Unit Abutment,
MUA, D-type #UAMD | |
| Dimensions | Diameter:3.75
Height: 1, 2, 3 | Diameter:3.75, regular
platform
Height: 1, 2, 3 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Angle | 17°, 30° | 17°, 30° | |
| Connection | Internal Hex | Internal Hex | |
| | | | |
| | | | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | Osstem Implant Co Ltd | |
| K Number | | K182091 | |
| Product Name | S35-S7 - S-lock Angular
Abutment | Port Angled Abutment&
Port Angled Abutment Head | |
| Dimensions | Diameter:3.75
Height: 1, 2, 3 | Diameter:4.63-4.82
Height: 1, 3 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Angle | 17°, 30° | 10°,17°, 30° | |
| Connection | Internal Hex | Internal Hex | |
| | | | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | Osstem Implant Co Ltd | |
| K Number | | K182091 | |
| Product Name | S5-S7 -Easy Fix Angular
Abutment | Port Angled Abutment&
Port Angled Abutment Head | |
| Dimensions | Diameter:3.75
Height: 1, 2, 3 | Diameter:4.63-4.82
Height: 1, 3 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Angle | 17°, 30° | 10°,17°, 30° | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | UNIQA Dental Itd | |
| K Number | S17 - The one-piece
angular Multi-unit Abutment | K180598
Angled Multi Unit Abutment,
MUA, D-type #UAMD | |
| Dimensions | Diameter:3.75
Height: 1, 2, 3,4,5 | Diameter:3.75, regular
platform
Height: 1, 2, 3 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Angle | 17°, 30° | 17°, 30° | |
| Connection | Internal Hex | Internal Hex/ | |
| Related
components | H-S16/S17 healing cap, T-
S16/S17 Titanium sleeve,
TW-S16/S17 Titanium
sleeve, T3-S16/S17 adaptor | The same | |
| | Candidate | Reference Device | Reference Device |
| | SGS International | UNIQA Dental Itd | |
| K Number | | K180598 | |
| Product Name | S7D Multi-Base Angular
Abutment | Angled Multi Unit Abutment,
MUA, D-type #UAMD | |
| Dimensions | Diameter:3.75
Height: 1, 2, 3 | Diameter:3.75, regular
platform
Height: 1, 2, 3 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Angle | 17°, 30° | 17°, 30° | |
| Connection | Conical | Internal Hex/conical | |
| Related
accessories | H-S6/S7 healing cap, T-
S6/S7 Titanium sleeve, TW-
S6/S7 Titanium sleeve, T3-
S6/S7 adaptor | The same | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | UNIQA Dental Itd | |
| K Number | | K180598 | |
| | S17D - The one angular
Multi-unit Abutment | Angled Multi Unit Abutment,
MUA, D-type #UAMD | |
| Dimensions | Diameter:3.75
Height: 1, 2, 3, 4, 5 | Diameter:3.75, regular
platform
Height: 1, 2, 3 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Angle | 17°, 30° | 17°, 30° | |
| Connection | Internal conical | Internal Hex/ | |
| Related
components | H-S16/S17 healing cap, T-
S16/S17 Titanium sleeve,
TW-S16/S17 Titanium
sleeve, T3-S16/S17
adaptor, | The same | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | UNIQA Dental Itd | |
| K Number | | K180598 | |
| Product Name | S16 , S16D - The straight
one-piece Multi-unit
Abutment | Straight Multi Unit Abutment,
MUA, D-type # USMD | |
| Dimensions | Diameter: 3.75
Height: 1, 2, 3, 4, 5; | Diameter:3.75 Regular
platform
Height: 1,2, 3,4, | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal hex(S16) / conical
(S16D) | Internal hex | |
| Related
components | H-S16/S17 healing cap, T-
S16/S17 Titanium sleeve,
TW-S16/S17 Titanium
sleeve, T3-S16/S17 adaptor | Sleeve, Healing Cap, plastic
cap | |
| | | | |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | Osstem Implant Co Ltd | |
| K Number | | K182091 | |
| Product Name | S35N, S35D,S35, S-Lock
Abutments | Port Abutment | |
| Dimensions | Narrow Diameter:3.0 Height:
1, 2, 3;
Regular Diameter: 3.75
Height: 1,2, 3,4,5,6 | Diameter: 3.5, 3.7, 4.1, 4.8,
5.1
Height: 1, 2, 3, 4, 5, 6, 7 | |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal conical | Internal hex | |
| | Candidate | Primary Predicate | Reference Device |
| | SGS International | SGS International | UNIQA Dental Itd |
| K Number | | K133362 | K180598 |
| Product Name | Ball Attachment S3D | Overdenture Ball attachment
S3N, S3 | Ball Attachment #UBAR |
| Dimensions | Normal: Length:1,2,3,4,5,6 | Narrow: Length:1,2,3,4
Normal: Length:1,2,3,4,5,6,7 | Regular platform: Height
0.5,1,2,3,4,5,6, 7 |
| Material | Titanium alloy Ti-6Al-4V-
ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| | Candidate | Reference Device | Reference Device |
| | SGS International Itd | A.B. Dental Devices | UNIQA Dental Itd |
| K Number | | K112440 | K180598 |
| Product Name | S4D Temporary Abutment
for immediate loading | P16 Straight adaptor
Temporary Abutment P15 | Straight Multi Unit Abutment,
MUA, C-type (Cat#UOMM) |
| Dimensions | Narrow Diameter 3.0, Profile
length 0.5, 1.5, 2.5,3.5
Regular Diameter 3.75,
Profile length 0.5, 1.5,
2.5,3.5 | Diameter 3.0, Profile length
1,2,3
Diameter 3.75, Profile length
1,2,3,4,5,6,7 | Mini Diameter: 4.0 Height 1,
2,3,4 (#UOMM)
Regular Diameter: 4.0, 5.0,
6.0 Height 1, 2,3,4,5 (5mm
not for 4Ø) (#UOMR) |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. |
| Connection | Internal Hex/conical | Internal Hex | Internal conical |
| | | | |
| | Candidate | Reference Device | |
| | SGS International Itd | Osstem Implant Co Ltd | |
| K Number | | K182091 | |
| Product Name | S5D Easy Fix Abutment
S8D Smart lock abutment | Port Abutment | |
| Dimensions | Narrow Diameter 3.0, Profile
length 0.5, 1.5, 2.5,3.5
Regular Diameter 3.75,
Profile length 0.5, 1.5,
2.5,3.5
(S8D) - Regular Diameter
3.75, Profile length
1,2,3,4,5,6 | Diameter: 3.5, 3.7, 4.1, 4.8,
5.1
Height: 1, 2, 3, 4, 5, 6, 7 | |
| Material | Titanium alloy Ti-6Al-4V-ELI. | Titanium alloy Ti-6Al-4V-ELI. | |
| Connection | Internal conical
Related components:
Metal/Silicon caps | Internal hex
Related components:
Metal/Silicon caps | |
11
Image /page/11/Picture/0 description: The image contains the logo for SGS Dental. The logo consists of an orange square with rounded corners, with white curved lines inside. To the right of the square is the text "SGS Dental", with "SGS" in black and "Dental" in orange. Below the logo is the text "SE - Dental Abutments:", with "SE" in black and "Dental Abutments" in black.
12
Image /page/12/Picture/0 description: The image is a logo for SGS Dental. The logo consists of two parts: a graphic on the left and the text "SGS Dental" on the right. The graphic is an orange square with rounded corners, inside of which are several white curved lines. The text "SGS" is in black, and the text "Dental" is in orange.
13
Image /page/13/Picture/0 description: The image is a logo for SGS Dental. The logo features a stylized image of a tooth on the left side, with the letters "SGS" in bold black font on the right side. Below the letters "SGS" is the word "Dental" in a smaller, orange font. The tooth image is orange and white and is set against a black background.
14
Image /page/14/Picture/0 description: The image contains the logo for SGS Dental. The logo consists of an orange square with rounded corners on the left side, with a black border on the left. Inside the square are five white curved lines. To the right of the square is the text "SGS" in black, with the word "Dental" underneath in orange.
15
Image /page/15/Picture/0 description: The image contains the logo for SGS Dental. The logo features a rounded square shape with an orange background and white curved lines inside. To the right of the shape is the text "SGS" in black, with the word "Dental" in orange below it.
16
Image /page/16/Picture/0 description: The image contains the logo for SGS Dental. The logo consists of two parts: a graphic on the left and the text "SGS Dental" on the right. The graphic is a rounded square with a black border on the left and an orange fill. Inside the orange area are four white curved lines. To the right of the graphic is the text "SGS" in black, with "Dental" underneath in orange.
17
Image /page/17/Picture/0 description: The image contains the logo for SGS Dental. The logo features a rounded square shape on the left side, divided into black and orange sections. The orange section contains a white, stylized image that resembles a spiral or a series of curved lines. To the right of the square is the text "SGS" in bold, black letters, with the word "Dental" underneath in orange.
| Candidate | Reference Device | Reference Device | |
|---|---|---|---|
| SGS International Itd | Osstem Implant Co Ltd | ||
| K Number | K182091 | ||
| Product Name | S5D-S7D Easy fix angular | ||
| abutment | Port Angled Abutment& | ||
| Port Angled Abutment Head | |||
| Dimensions | Diameter: 3.75 | ||
| Height: 1, 2, 3; | Diameter:4.63-4.82 | ||
| Height: 1, 3 | |||
| Material | Titanium alloy Ti-6Al-4V- | ||
| ELI. | Titanium alloy Ti-6AI-4V-ELI. | ||
| Angle | 17°, 30° | 10°,17°, 30° | |
| Connection | Internal conical | Internal Hex | |
18
Image /page/18/Picture/0 description: The image contains the logo for SGS Dental. The logo features an orange square with rounded corners on the left side, containing a stylized white graphic that resembles a series of curved lines. To the right of the graphic, the letters "SGS" are written in a bold, black font. Below "SGS", the word "Dental" is written in a smaller, orange font.
| Candidate | Reference Device | ||
|---|---|---|---|
| SGS International Itd | UNIQA Dental Itd | ||
| K Number | K180598 | ||
| Product Name | S8D-15 - Smart Lock | ||
| angular abutments | Angled Multi Unit Abutment, | ||
| MUA, D-type #UAMD | |||
| Dimensions | Diameter: 3.75 | ||
| Height: 1.5, 3; | Diameter:3.75 regular platform | ||
| Height: 1, 2, 3 | |||
| Material | Titanium alloy Ti-6Al-4V- | ||
| ELI. | Titanium alloy Ti-6Al-4V-ELI. | ||
| Angle | 15° | 17°, 30° | |
| Connection | Internal conical | Internal Hex/ | |
| Candidate | Reference Device | Reference Device | |
| SGS International Itd | UNIQA Dental Itd | ||
| K Number | K180598 | ||
| Product Name | S15D-PT Flat connection | ||
| abutment for casting | |||
| S15D-T Flat connection | |||
| straight abutment | Angled Multi Unit Abutment, | ||
| MUA, D-type #UAMD | |||
| Dimensions | Diameter: 3.75 Length 15 | ||
| mm | Diameter:3.75 Regular | ||
| platform | |||
| Height: 1,2,3 | |||
| Material | Titanium alloy Ti-6Al-4V- | ||
| ELI. | Titanium alloy Ti-6Al-4V-ELI. | ||
| Connection | Internal conical | Internal Hex/ | |
14 Summary of Equivalence:
SE - Indication for Use Discussion -
SGS® Dental Implants - share the same indication for use as its previous submission and current Primary Predicate: SGS® International Ltd K133362. The only difference is that the Primary Predicate SGS® International Ltd K133362 was introducing more implants' design and as such has provided more details for the indication for use. In current submission SGS introduces the same implants' design only having conical connection, as such no differences are applied to the indication for use.
SGS® Dental Abutments - share the same indication for use as its previous submission and current Primary Predicate: SGS® International Ltd K133362; Since SGS® is introducing new abutments design which were not included in previous submission then the following similar reference devices have been indicated: UNIQA Dental Itd K180598; A.B.Dental Devices K112440; Osstem Implant Co Ltd K182091; Review of the reference devices indication for use raises no differences compare to SGS® but only minor wording
19
Image /page/19/Picture/0 description: The image is a logo for SGS Dental. The logo consists of two parts: a graphic on the left and the text "SGS Dental" on the right. The graphic is an orange square with rounded corners, inside of which are several white curved lines that resemble a stylized globe. The text "SGS" is in black, and "Dental" is in orange.
therefore, SGS® Dental Implants/Abutments system is considered to be substantially equivalent to its Primary predicate and reference devices.
SE - Dental Implants, Dental Abutment -
As demonstrated by the substantial equivalent table SGS® Dental Implants System shares similarity to its Primary predicate SGS International Ltd K133362; and Reference Devices: UNIQA Dental Itd K180598; A.B.Dental Devices K112440; Osstem Implant Co Ltd K182091; in terms of indication for use, intended use, technological characteristics, raw material, design, measurements, surface treatment, sterilization method and performance.
Minor differences are related to implants' measurements but are still in the range of the Primary Predicate SGS K133362.
Minor differences are related to the abutments' measurements but are still in the range of the reference devices: UNIQA Dental Itd K180598; A.B.Dental Devices K112440; Osstem Implant Co Ltd K182091;
The differences have been assessed by Fatigue testing per ISO 14801:2007 which have demonstrated good results, therefore SGS® Dental Implants system is considered to be substantially equivalent to its predicate devices. In respect of the subject SGS Angular Abutments S2D-29 the change of technology from the multi-unit reference device UNIQA Dental Itd K180598 to single-unit the Angular Abutments S2D-29, was addressed by Fatigue testing per ISO 14801:2007.
15 Performance Testing :
Clinical Testing - No clinical data is included in this submission.
Sterilization Validation Test was carried out with SGS to ISO 11137 - Test results have demonstrated that the SAL of 10-® was achieved and all testing requirements were met. Shelf Life Test was carried out with accordance to ASTM F-1980 in order to validate the claimed shelf life of 5 years.
Steam Sterilization Test was carried out with accordance to ISO 17665 - Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Biocompatibility - SGS Dental Implants are made of Ti6Al4V ELI using the conventional manufacturing process. Biocompatibility testing per the FDA Guidance Use of ISO 10993-1 was leveraged from the Primary Predicate.
Fatigue test were carried out with accordance to ISO 14801 in order to verify the mechanical connection strength of implant/abutment, results have demonstrated the performance with the use of SGS® Dental Implants / Abutments.
20
Image /page/20/Picture/0 description: The image contains the logo for SGS Dental. The logo features an orange square with rounded corners on the left side, containing a black shape and white curved lines. To the right of the square, the text "SGS" is written in black, with "Dental" written in orange below it.
Risk Assessment was carried out with accordance to ISO 14971.
16 Conclusion
As verified by substantial equivalence, risk assessment and bench testing SGS® Dental Implants System shares similarity with its predicated devices in terms of intended use, indication for use, raw material, technological characteristics and performance. Therefore, SGS® Dental Implants system is considered to be substantially equivalent to its predicate devices.