← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K182219 # SGS Dental Implants System (K182219) _Sgs International, Ltd. · DZE · Aug 29, 2019 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K182219 ## Device Facts - **Applicant:** Sgs International, Ltd. - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Aug 29, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended 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. ## Device Story SGS Dental Implants System consists of endosseous root-form dental implants and various abutments; used for supporting prosthetic restorations (crowns, bridges, overdentures). Implants are surgically placed in maxillary or mandibular bone by dental professionals. System includes internal hex and internal conical connection designs; various diameters and lengths available. Abutments include healing, straight, anatomic, angular, ball attachment, and PEEK temporary types. Device functions by osseointegration of the implant into the jawbone, providing a stable base for prosthetic attachment. Clinical benefit includes restoration of chewing function and aesthetics for edentulous or partially edentulous patients. System is provided sterile; some components are CNC machined from titanium alloy (Ti 6Al-4V ELI). ## Clinical Evidence No clinical data included. Evidence consists of bench testing: fatigue testing per ISO 14801, sterilization validation (gamma and steam) per ISO 11137 and ISO 17665, shelf-life validation per ASTM F-1980, and biocompatibility assessment leveraged from the primary predicate. ## Technological Characteristics Materials: Ti 6Al-4V ELI (ASTM F-136/ISO 5832-3) and PEEK-CLASSIX. Design: Endosseous root-form, internal hex or internal conical connections, tapered or straight thread designs. Surface treatment: Calcium Phosphate. Sterilization: Gamma radiation or moist heat (steam). ## Regulatory 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 - SGS International Ltd ([K133362](/device/K133362.md)) ## Reference Devices - UNIQA Dental Ltd ([K180598](/device/K180598.md)) - A.B. Dental Devices ([K112440](/device/K112440.md)) - Osstem Implant Co Ltd ([K182091](/device/K182091.md)) ## Related Devices - [K133362](/device/K133362.md) — SGS DENTAL IMPLANT · Sgs International, Ltd. · Nov 21, 2014 - [K240966](/device/K240966.md) — Prima Plus Conical Implant System · Keystone Dental, Inc. · Jul 9, 2024 - [K233137](/device/K233137.md) — Ticare Dental Implant Systems · Mozograu S.A. · May 16, 2024 - [K111003](/device/K111003.md) — BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL · Biodenta Swiss AG · Sep 15, 2011 - [K231426](/device/K231426.md) — 8plant Implant System · Hoowon Edi Co., Ltd. · May 24, 2024 ## Submission Summary (Full Text) {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<br>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<br>use | SGS® Dental Implants<br>System is intended for<br>surgical placement in the<br>maxillary and/or mandibular<br>arch to support crowns,<br>bridges, or overdentures in<br>edentulous or partially<br>edentulous patients. SGS®<br>Dental Implants System may<br>be immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal loading.<br>Narrow diameter implants<br>(3.2) are intended for<br>maxillary lateral incisors and<br>mandibular lateral and central<br>incisors.<br>Two Stage Implants: P7N,<br>P1D, P5D, P7D. PEEK<br>Temporary Abutments are<br>not to exceed 30 days. | SGS® Dental Implants System<br>is intended for surgical<br>placement in the maxillary<br>and/or mandibular arch to<br>support crowns, bridges, or<br>overdentures in edentulous or<br>partially edentulous patients.<br>SGS® Dental Implants System<br>may be immediate loading<br>when good primary stability is<br>achieved and with appropriate<br>occlusal loading.<br>Two Stage Implants: P1, P7,<br>P7N.<br>One Stage: P7S, P9S.<br>One Stage & One-Piece 3.0<br>mm diameter implants: P7S,<br>P9S are intended for<br>placement at the mandibular<br>central and lateral incisors and<br>maxillary and lateral incisors.<br>Indicated also for denture<br>stabilization using multiple<br>implants.<br>One stage & One-Piece 2.4<br>mm diameter implants for<br>temporary use or long term<br>use:<br>P9S permit immediate splint<br>stability and long term fixation<br>of new or existing crown,<br>bridge and prosthesis, and<br>protection of graft sites.<br>PEEK Temporary Abutments<br>are not to exceed 30 days. | UNIQA Dental ® Dental<br>Implants System is indicated<br>for use in surgical and<br>restorative applications for<br>placement in the bone of the<br>upper or lower jaw to provide<br>support for prosthetic devices,<br>such as artificial teeth, in order<br>to restore the patient's chewing<br>function. UNIQA Dental ®<br>Dental Implants System is<br>indicated also for immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading.<br>UNIQA Conical Connection<br>Implants: #UCI & #UC7 are to<br>be used only with straight<br>abutments.<br>Conical Mini implants<br>(Ø3.3mm) are indicated for use<br>in surgical and restorative<br>applications for placement only<br>in the mandibular central,<br>lateral incisor and maxillary<br>lateral incisor regions of<br>partially edentulous jaws, to<br>provide support for prosthetic<br>devices such as artificial teeth,<br>in order to restore the patient'<br>chewing function. Mandibular<br>central and lateral incisors<br>must be splinted if using two or<br>more narrow implants adjacent<br>to one another. | | | Reference Device | Reference Device | Reference Device | | | Osstem Implant Co Ltd | A.B. Dental Devices | | | K Number | K182091 | K112440 | | | Indication for<br>use | Osstem Abutment System is<br>intended for use with a dental<br>implant to provide support for<br>prosthetic restorations such<br>as crowns, bridges, or<br>overdentures. | The AB Dental Devices<br>implants are intended for<br>surgical placement in the<br>maxillary and/or mandibular<br>arch to support crowns,<br>bridges, or overdentures in<br>edentulous or partially<br>edentulous patients. I7 Integral<br>implant, I5 Conical implant,<br>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<br>P7N Narrow Conical Implant | Primary Predicate<br>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<br>Ø / Length mm | 3.2Ø: 8 | 3.2Ø: 8, 10, 11.5<br>3.75Ø: 8, 10, 11.5, 13, 16<br>4.2Ø: 8, 10, 11.5, 13, 16<br>4.5Ø: 8, 10, 11.5, 13, 16<br>5.0Ø: 8, 10, 11.5, 13, 16<br>6.0Ø: 8, 10, 11.5, 13, 16 | | Connection Type | Internal Hex | Internal Hex | | Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI | | Surface<br>Treatment | Calcium Phosphate | Calcium Phosphate | | Self tapping | Yes | Yes | | Sterilization | Gamma Ray | Gamma Ray | | Packaging | Double packaging | Double packaging | | Characteristic | Candidate<br>P1D Conical Groovy Double<br>Connection Implant | Primary Predicate<br>P1 Screw Type Groovy Implant | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | TBD | K133362 | | Manufacturer | SGS International Ltd. | SGS International Ltd. | | Product Name | P1D Conical Groovy Double<br>Connection Implant | P1 Screw Type Groovy Implant | | Thread Design | Straight | Tapered, Double Thread | | Measurements<br>Ø / Length mm | 3.5Ø: 8, 10, 11.5, 13, 16<br>3.75Ø: 8, 10, 11.5, 13, 16<br>4.2Ø: 8, 10, 11.5, 13, 16<br>5Ø: 8, 10, 11.5, 13, 16<br>6Ø: 8, 10, 11.5, 13, 16 | 3.2Ø: 8, 10, 11.5<br>3.75Ø: 8, 10, 11.5, 13, 16<br>4.2Ø: 8, 10, 11.5, 13, 16<br>4.5Ø: 8, 10, 11.5, 13, 16<br>5Ø: 8, 10, 11.5, 13, 16<br>6Ø: 8, 10, 11.5, 13, 16 | | Connection Type | Internal conical | Internal Hex | | Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI | | Surface<br>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<br>P5D Conical Groovy Double<br>Connection Implant | Primary Predicate<br>P7 Conical Groovy Implant | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | TBD | K133362 | | Manufacturer | SGS International Ltd. | SGS International Ltd. | | Product Name | P5D Conical Groovy Double Connection<br>Implant | P7 Conical Groovy Implant | | Thread Design | Tapered, Double Thread | Tapered, Double Thread | | Measurements<br>Ø / Length mm | 3.50Ø: 8, 10, 11.5, 13, 16<br>3.75Ø: 8, 10, 11.5, 13, 16<br>4.20Ø: 8, 10, 11.5, 13, 16<br>4.50Ø: 8, 10, 11.5, 13, 16<br>5.00Ø: 8, 10, 11.5, 13, 16<br>6.00Ø: 8, 10, 11.5, 13, 16 | 3.20Ø: 8, 10, 11.5<br>3.75Ø: 8, 10, 11.5, 13, 16<br>4.20Ø: 8, 10, 11.5, 13, 16<br>4.50Ø: 8, 10, 11.5, 13, 16<br>5.00Ø: 8, 10, 11.5, 13, 16<br>6.00Ø: 8, 10, 11.5, 13, 16 | | Connection Type | Internal conical | Internal Hex | | Material | Ti 6Al-4V ELI | Ti 6Al-4V ELI | | Surface<br>Treatment | Calcium Phosphate | Calcium Phosphate | | Self tapping | Yes | Yes | | Sterilization | Gamma Ray | Gamma Ray | | Packaging | Double packaging | Double packaging | | Characteristic | Candidate<br>P7D - Dental Implant with Double<br>Connection | Primary Predicate<br>P7 Conical Groovy Implant | | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | TBD | K133362 | | | Manufacturer | SGS International Ltd. | SGS International Ltd. | | | Product Name | P7D - Dental Implant with Double<br>Connection | P7 Conical Groovy Implant | | | Thread Design | Tapered, Double Thread | Tapered, Double Thread | | | Measurements<br>Ø / Length mm | 3.50 Ø: 8, 10, 11.5, 13, 16<br>3.75Ø: 8, 10, 11.5, 13, 16<br>4.20 Ø: 8, 10, 11.5, 13, 16<br>4.5Ø: 8, 10, 11.5, 13, 16<br>5.00 Ø: 8, 10, 11.5, 13, 16<br>6.00 Ø: 8, 10, 11.5, 13, 16 | 3.20 Ø: 8, 10, 11.5<br>3.75Ø:8, 10, 11.5, 13, 16<br>4.20 Ø: 8, 10, 11.5, 13, 16<br>4.5Ø: 8, 10, 11.5, 13, 16<br>5.00 Ø: 8, 10, 11.5, 13, 16<br>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<br>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<br>(HD,HND,HW7D,HW8D,H<br>WD) | Healing Abutments<br>(HN,HNN,HWN,H,HN, HW) | Healing Cap # UOHX | | Dimensions | Narrow, Length: wide 2,3,4;<br>Normal, Length: 2,3,4,5,6<br>Wide, Length: 3,5 | Narrow, Length: 2,3,4<br>Normal, Length: 2,3,4,5,6<br>Wide, Length: 3,5 | Diameter: Mini (#UOHM) -<br>Diameter 4.0, 4.5 Heights 3,<br>4, 5,7<br>Regular (#UOHR) -<br>Diameter 4.0, 4.5, 5.0, 6.0,<br>7.0 Heights 3, 4, 5, 7 | | Material | Titanium alloy Ti-6Al-4V-<br>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<br>Abutment S1AD | Anatomic Straight Titanium<br>Abutment S1A, S1AN | Transfer Abutment #UOTX | | Dimensions | Normal Profile: Height 1, 2,<br>3 mm | Narrow: Straight Anatomic<br>Abutment-Profile Height 1<br>mm<br>Normal: Profile Height 1, 2, 3<br>mm | Mini Diameter: 4.5 mm,<br>Height 1, 2, 3, 4, 5 mm<br>Lengths: 5.5, 7 mm (#UOTM)<br>Regular Diameter: 4.5, 5.0,<br>6.0 mm, Height 1, 2, 3, 4, 5<br>mm, Lengths: 4.0(not for 4.5),<br>5.5, 7 mm(#UOTR)<br>Provided with: Screw Mini<br>Conical (#UOSM-0001);<br>Screw Regular Conical<br>(#UOSR-0001) | | Material | Titanium alloy Ti-6Al-4V-<br>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<br>S1WN,S1D, S1ND, S1WD,<br>S1W, S1W8D, S1W8 | Straight Titanium Abutment<br>S1N,S1WN, S1,S1N,S1W | Transfer Abutment #UOTX | | Dimensions | Narrow: Wide - Length:9<br>Normal: Length: 7, 9, 12, 15<br>Narrow: Length: 7, 9<br>Wide: Length:9, 12<br>S1W8D, S1W8 - 8mm wide<br>with 10mm length | Narrow: Narrow, Wide -<br>Length:9<br>Normal: Length: 5, 7, 9, 12, 15<br>Narrow: Length: 7, 9<br>Wide: Length:9 | Mini Diameter: 4.5 mm,<br>Height 1, 2, 3, 4, 5 mm<br>Lengths: 5.5, 7 mm (#UOTM)<br>Regular Diameter: 4.5, 5.0,<br>6.0 mm, Height 1, 2, 3, 4, 5<br>mm, Lengths: 4.0(not for 4.5), | | |… --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K182219](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K182219) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K182219