(216 days)
No
The 510(k) summary describes physical dental implants and associated components. There is no mention of software, algorithms, image processing, or any other technology that would typically incorporate AI/ML. The performance studies focus on material properties, sterilization, and mechanical testing.
Yes
The device is a dental implant system used to provide support for restorations. This is a therapeutic function as it treats the absence of teeth by providing a base for prosthetic replacements.
No
Explanation: The device is a dental implant system designed to provide support for dental restorations. Its intended use is for placement in the mouth and immediate loading under certain conditions, which are therapeutic functions, not diagnostic.
No
The device description explicitly lists physical components such as implants, abutments, healing caps, and abutment screws, which are hardware. The performance studies also focus on the physical properties and sterilization of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations." This describes a surgical implant used within the body for structural support.
- Device Description: The description details various components of a dental implant system, including implants, abutments, healing caps, and screws. These are all physical devices intended for surgical implantation and mechanical support.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a structural implant.
N/A
# Intended Use / Indications for Use
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
# Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
# Device Description
The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in [K170392](https://510k.innolitics.com/search/K170392) and [K170398](https://510k.innolitics.com/search/K170398). This submission adds the following components to the S.I.N. Dental Implant System:
Tryon CM Conical implants, Tryon CM Cylindrical implants, Tryon CM Cylindrical Body and Conical Apex implants, and Strong SW implants, each with a Morse taper connection and the identical acidetched endosseous surface cleared in in [K170392](https://510k.innolitics.com/search/K170392);
Strong SW Plus implants with a Morse taper connection and an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M) identical to the coating cleared in [K170392](https://510k.innolitics.com/search/K170392):
conventional angled abutments and healing caps with a Morse taper connection that are compatible with the Strong SW CM implant line cleared in [K170392](https://510k.innolitics.com/search/K170392);
conventional angled abutments and healing caps with a Morse taper connection that are compatible with the subject device Tryon CM implant lines, the subject device Strong SW/Plus implant lines, and the Unitite implant line cleared in K17039;
healing caps with a Morse taper connection that are compatible with the Unitite Compact implant line and the Unitite Slim implant line cleared in [K170392](https://510k.innolitics.com/search/K170392);
healing caps with an external hex (HE) or internal hex (HI) connection that are compatible with the Strong SW HE, the Tryon HE implant lines, and the Strong SW HI implant lines, cleared in [K170398](https://510k.innolitics.com/search/K170398);
abutment screws for use with the angled abutments or healing caps.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
maxillary 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)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
gamma irradiation sterilization validated for all subject devices (dental implants manufactured from unalloyed titanium with the acid-etched surface and implants with the HA™® hydroxyapatite coating, abutments and prosthetic components manufactured from titanium alloy, and healing caps manufactured from PEEK) to a sterility assurance level of 10th by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2;
bacterial endotoxin testing (referenced from [K170398](https://510k.innolitics.com/search/K170398) and [K170392](https://510k.innolitics.com/search/K170392)) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of
§ 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.
November 17, 2020
S.I.N.-Sistema de Implante Nacional S.A. % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International. LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K200992
Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 16, 2020 Received: October 16, 2020
Dear Kevin Thomas:
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 (OS) 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. 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
Indications for Use
510(k) Number (if known)
Device Name
S.I.N. Dental Implant System
Indications for Use (Describe)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to single-unit or multi-unit restorations. When a one-stage surgical is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K200992 S.I.N. - Sistema de Implante Nacional S.A. S.I.N Dental Implant System
November 17, 2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | S.I.N. - Sistema de Implante Nacional S.A. | ||||
|---|---|---|---|---|---|
| Avenida Vereador Abel Ferreira, 1100 | |||||
| São Paulo, São Paulo | |||||
| 03340-000 Brazil | |||||
| Telephone: +55-11-21693000 ext 3236 | |||||
| Official Contact | Denise Domiciano, Quality and Regulatory Manager | ||||
| Representative/Consultant | Kevin A. Thomas, PhD | ||||
| Floyd G. Larson, MS, MBA | |||||
| PaxMed International, LLC | |||||
| 12264 El Camino Real, Suite 400 | |||||
| San Diego, CA 92130 | |||||
| Telephone: | +1 858-792-1235 | ||||
| Fax: | +1 858-792-1236 | ||||
| Email: | kthomas@paxmed.com | ||||
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | S.I.N. Dental Implant System |
|---|---|
| Common Names | Endosseous dental implant |
| Regulation Number | 21 CFR 872.3640 |
| Regulation Name | Endosseous dental implant |
| Regulatory Class | Class II |
| Product Code | DZE |
| Secondary Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Health Technology 1 B (Dental Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K170392, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A.
Additional Predicate Devices
K170398, S.I.N. Dental Implant System, S.I.N. - Sistema de Implante Nacional S.A. K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K101945, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentários SA
4
K961736, 17° Angulated Abutment, Nobel Biocare USA, LLC K905434, Angulated Abutment, Complete, Titanium SDCA 102, Nobelpharma USA, Inc. K161416, Multi-unit Abutment Plus, Nobel Biocare AB K052600, Zimmer Dental Incorporated, Zimmer Dental Hex-lock Prepared Abutment (Straight & Angled) K110955, MegaGen Company, Limited, AnyRidge Internal Implant System
INDICATIONS FOR USE STATEMENT
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. This submission adds the following components to the S.I.N. Dental Implant System:
Tryon CM Conical implants, Tryon CM Cylindrical implants, Tryon CM Cylindrical Body and Conical Apex implants, and Strong SW implants, each with a Morse taper connection and the identical acidetched endosseous surface cleared in in K170392;
Strong SW Plus implants with a Morse taper connection and an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M) identical to the coating cleared in K170392:
conventional angled abutments and healing caps with a Morse taper connection that are compatible with the Strong SW CM implant line cleared in K170392;
conventional angled abutments and healing caps with a Morse taper connection that are compatible with the subject device Tryon CM implant lines, the subject device Strong SW/Plus implant lines, and the Unitite implant line cleared in K17039;
healing caps with a Morse taper connection that are compatible with the Unitite Compact implant line and the Unitite Slim implant line cleared in K170392;
healing caps with an external hex (HE) or internal hex (HI) connection that are compatible with the Strong SW HE, the Tryon HE implant lines, and the Strong SW HI implant lines, cleared in K170398;
abutment screws for use with the angled abutments or healing caps.
| Implant Line | Body Ø, mm | Platform Ø, mm | Length, mm | |||||
|---|---|---|---|---|---|---|---|---|
| Tryon CM Conical | 3.5 | 3.5 | 8.5 | 10 | 11.5 | 13 | 15 | |
| Tryon CM Conical | 4.5 | 4.5 | 8.5 | 10 | 11.5 | 13 | 15 | |
| Tryon CM Conical | 5.0 | 5.0 | 8.5 | 10 | 11.5 | 13 | 15 | |
| Tryon CM Cylindrical | 3.5 | 3.5 | 7 | 8.5 | 10 | 11.5 | 13 | 15 |
| Tryon CM Cylindrical | 3.75 | 3.75 | 7 | 8.5 | 10 | 11.5 | 13 | 15 |
| Tryon CM Cylindrical | 4.0 | 4.0 | 7 | 8.5 | 10 | 11.5 | 13 | 15 |
| Tryon CM Cylindrical | 5.0 | 5.0 | 7 | 8.5 | 10 | 11.5 | 13 | 15 |
The subject device dental implants are summarized in the following table.
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| Implant Line | Body Ø, mm | Platform Ø, mm | Length, mm | |||||
|---|---|---|---|---|---|---|---|---|
| Tryon CM Cylindrical Body | ||||||||
| and Conical Apex | 3.5 | 3.5 | 8.5 | 10 | 11.5 | 13 | 15 | |
| 3.75 | 3.75 | 8.5 | 10 | 11.5 | 13 | 15 | ||
| 4.0 | 4.0 | 8.5 | 10 | 11.5 | 13 | 15 | ||
| Strong SW | 3.5 | 3.5 | 8.5 | 10 | 11.5 | 13 | 15 | |
| 3.8 | 3.8 | 8.5 | 10 | 11.5 | 13 | 15 | ||
| Strong SW Plus | 4.5 | 4.5 | 8.5 | 10 | 11.5 | 13 | 15 | |
| 5.0 | 5.0 | 8.5 | 10 | 11.5 | 13 | 15 |
All subject device dental implants are made of the same unalloyed titanium as the dental implants cleared in K170398 and K170392, and the Strong SW Plus implants have the identical HA™® surface cleared in K170392.
Prosthetic Components
The subject device prosthetic components are summarized in the following table.
| Types | Prosthetic Platform Ø, mm | Angle | Materials | Compatible with |
|---|---|---|---|---|
| Abutment Cemented Morse Angled | ||||
| (16° Morse taper) | 3.3, 4.5 | 17°, 30° | Titanium alloy | |
| Abutment Angled Morse | ||||
| (16° Morse taper) | 3.5, 4.5 | 17° | Titanium alloy | |
| Abutment Mini Angled Morse | ||||
| (16° Morse taper) | 4.8 | 17°, 30° | Titanium alloy | Strong SW CM |
| implant line in | ||||
| K170392 | ||||
| Healing Cap Morse | ||||
| (16° Morse taper) | n/a | n/a | PEEK | |
| Healing Cap Morse Indexed | ||||
| (16° Morse taper) | n/a | n/a | PEEK | |
| Abutment Cemented Angled SIT | ||||
| (11.5° Morse taper) | 3.3, 4.5 | 17°, 30° | Titanium alloy | |
| Abutment Cemented Angled Indexed SIT | ||||
| (11.5° Morse taper) | 3.3, 4.5 | 17°, 30° | Titanium alloy | Tryon CM implant |
| lines, Strong SW, | ||||
| Abutment Mini Angled | ||||
| (11.5° Morse taper) | 4.8 | 17°, 30° | Titanium alloy | Strong SW Plus (this |
| submission); | ||||
| Healing Cap | ||||
| (11.5° Morse taper) | n/a | n/a | PEEK | Unitite implant line in |
| K170392 | ||||
| Healing Cap Indexed | ||||
| (11.5° Morse taper) | n/a | n/a | PEEK | |
| Healing Cap Compact | ||||
| (4° Morse taper) | n/a | n/a | PEEK | Unitite Compact |
| implant line in | ||||
| Healing Cap Compact Indexed | ||||
| (4° Morse taper) | n/a | n/a | PEEK | K170392 |
| Healing Cap Slim | ||||
| (3° Morse taper) | n/a | n/a | PEEK | Unitite Slim implant |
| line in K170392 | ||||
| Healing Cap Slim Indexed | ||||
| (3° Morse taper) | n/a | n/a | PEEK | |
| Healing Cap HE | n/a | n/a | PEEK | Strong SW HE and |
| Tryon HE implant | ||||
| lines in K170398 | ||||
| Healing Cap HE Indexed | n/a | n/a | PEEK | |
| Healing Cap HI | n/a | n/a | PEEK | Strong SW HI implant |
| Healing Cap HI Indexed | n/a | n/a | PEEK | line in K170398 |
All subject device prosthetic components are manufactured from the same titanium alloy material conforming to ASTM F136 used to manufacture similar components abutments cleared in K170392 and K 170398, or from polyetheretherketone (PEEK) conforming to ASTM F2026.
6
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
gamma irradiation sterilization validated for all subject devices (dental implants manufactured from unalloyed titanium with the acid-etched surface and implants with the HA™® hydroxyapatite coating, abutments and prosthetic components manufactured from titanium alloy, and healing caps manufactured from PEEK) to a sterility assurance level of 10th by selecting and substantiating a 25 kGy dose using method VDmax25, according to ISO 11137-1 and ISO 11137-2;
bacterial endotoxin testing (referenced from K170398 and K170392) including Limulus amebocyte lysate (LAL) test according to ANSI/AAMI ST72 on samples of water used in manufacturing on a weekly basis and on samples from sterilized product on a quarterly basis to demonstrate all sterile product meets a limit of