← Product Code [DZE](/productcode/DZE) · K210489
# SICtapered & SICvantage tapered (K210489)
_Sic Invent AG · DZE · Mar 17, 2022 · Dental · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K210489
## Device Facts
- **Applicant:** Sic Invent AG
- **Product Code:** [DZE](/productcode/DZE.md)
- **Decision Date:** Mar 17, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3640
- **Device Class:** Class 2
- **Review Panel:** Dental
- **Attributes:** Therapeutic
## Indications for Use
SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICtapered implants with Ø 3.7 mm Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme. SICvantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading. Only applicable for SICvantage tapered implants with Ø 3.0 mm Use without splinting is permissible in the anterior replacement of maxillary lateral incisors and mandbular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
## Device Story
Two-part, self-tapping, endosteal threaded dental implants; conical shape with apical cutting edge; cylindrical cortical area; platform switching crestal bevel; decompression zone. Manufactured from medical-grade pure titanium. Used in dental/oromaxillofacial surgery to support prosthetic restorations. Operated by dental professionals. Inputs: surgical site preparation; outputs: stable base for prosthetic attachment. Benefits: restoration of chewing function. Sterilized via irradiation.
## Clinical Evidence
Bench testing only. Performance validated via mechanical fatigue testing (EN ISO 14801), biocompatibility (ISO 10993-5/12), sterility (SAL 10^-6), and shelf-life validation. Data leveraged from predicate devices (K173207) where applicable due to identical materials, surface treatments, and sterilization processes.
## Technological Characteristics
Materials: Titanium Grade 4 (ISO 5832-2 / ASTM F67). Design: Two-piece, self-tapping, endosteal threaded. Surface: Sandblasted and etched. Connection: Inner hexagon (SICtapered) or Morse taper with Swiss cross (SICvantage tapered). Sterilization: Irradiation. Connectivity: N/A (mechanical device).
## 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
- SICmax ([K173207](/device/K173207.md))
- SICvantage max ([K173207](/device/K173207.md))
## Reference Devices
- Legacy3 6mm Length Implants ([K131097](/device/K131097.md))
- OsseoSpeed Profile EV Ø 3.0 mm / 8.00 mm ([K120414](/device/K120414.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
SIC invent AG Cretia McNett Chief Regulatory Officer Birmannsgasse 3 Basel, CH-4055 SWITZERLAND
Re: K210489
Trade/Device Name: SICtapered & SICvantage tapered Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 7, 2022 Received: February 17, 2022
Dear Cretia McNett:
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.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K210489
Device Name SICtapered & SICvantage tapered
# Indications for Use (Describe)
SICtapered
SICtapered Implants are intended for use during dental implantation and oromaxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for when adequate primary stability is achieved and with appropriate occlusal loading.
Only applicable for SICtapered implants with Ø 3.7 mm
Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
SICvantage tapered
SIC vantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
Only applicable for SICvantage tapered implants with Ø 3.0 mm
Use without splinting is permissible in the anterior replacement of maxillary lateral incisors and mandbular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|
|--------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C)
|
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
SIC invent AG SICtapered & SICvantage tapered 510(k) Premarket Notification
Image /page/3/Picture/2 description: The image shows a red circle with the letters "SIC" in the center. The letters are also red. There is a circled "R" symbol in the upper right corner of the circle. The background is white.
DATE PREPARED: March 17, 2022 APPLICANT: SIC invent AG Birmannsgasse 3 4055 Basel Switzerland Tel: + 49 55150429440 Mobile: +49 15121349184 E-Mail: Cretia.McNett@sic-invent.com CONTACT PERSON: Cretia McNett Chief Regulatory Officer Tel: + 49 55150429440 E-Mail: Cretia.McNett@sic-invent.com
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows a red circle with the letters "SIC" in the center, also in red. There is a small "R" in a circle in the upper right corner of the circle. The logo is simple and clean, with a focus on the acronym "SIC".
### 1 Device Name
| Trade Name: | SICtapered & SICvantage tapered |
|-----------------------------|---------------------------------|
| Common Name: | SICtapered & SICvantage tapered |
| Device Classification Name: | Endosseous dental implant |
### Classification / Product Code 2
SICtapered & SICvantage tapered can be classified according to following device name and product code:
| Device | Regulation
Description | Regulation
Medical
Specialty | Review Panel | Product Code | Regulation
Number | Device
Classification |
|-----------------------|------------------------------|------------------------------------|--------------|--------------|----------------------|--------------------------|
| SICtapered | Endosseous
dental implant | Dental | Dental | DZE | 872.3640 | 2 |
| SICvantage
tapered | Endosseous
dental implant | Dental | Dental | DZE | 872.3640 | 2 |
### Predicate Device / Reference Device 3
| Device | Predicate Device | Reference Device | Reference Device
2 | 510(k) Number | 510(k) Holder |
|------------------------------------------|------------------|--------------------------------|-----------------------------------------------------------------------------------------|---------------|--------------------------------------------------------------------------|
| SICtapered | SICmax | -- | -- | K173207 | SIC invent AG |
| SICvantage tapered | SICvantage max | -- | -- | K173207 | |
| SICtapered Ø 3.7
mm / 7.25 mm | -- | Legacy3 6mm Length
Implants | -- | K131097 | Implant Direct Sybron
Manufacturing Llc |
| SICvantage tapered
Ø 3.0 mm / 9.25 mm | -- | -- | OsseoSpeed
Profile EV Ø 3.0
mm / 8.00 mm
(previously named
OsseoSpeed Plus) | K120414 | Dentsply Implants
Manufacturing GmbH
(previously Astra Tech
AB) |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows a red circle with the letters "SIC" in red inside the circle. There is a small "R" in a circle in the upper right corner of the larger circle. The letters "SIC" are in a sans-serif font and are centered within the circle. The red color is consistent throughout the image.
#### 4 Device Description
#### Dental implant SICtapered 4.1
The SICtapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The vertical fixation screw is secured with a torque of 20 Ncm. The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation.
| Implant Sizes: | | | | | |
|----------------|-------------|-------------|-------------|-------------|-------------|
| Diameter [mm] | Length [mm] | Length [mm] | Length [mm] | Length [mm] | Length [mm] |
| 3.70 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 4.20 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 4.70 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 5.15 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
The table shows which implant body combinations are available.
#### Dental implant SICvantage tapered 4.2
The SICvantage tapered is a two-part, self-tapping, endosteal threaded implant. The basic shape is conical with an initially tapered "apical cutting edge". The cortical area is cylindrical, and the core diameter is increased. On the top of the implant, there is a decompression zone to reduce the compression on the bone and a crestal bevel designed for "platform switching". The apex has an aggressive cut with a large flute for good chip clearance. The SICvantage tapered can be used in all bone qualities (D1 – D4). The implants are manufactured from medical-grade pure titanium (ISO 5832-2). The microstructuring of the surface is achieved by abrasive processes. Surgical accessories and prosthetic abutments are usually color-coded by means of anodized oxidation.
Implant Sizes:
| Diameter
[mm] | Length
[mm] | Length
[mm] | Length
[mm] | Length
[mm] | Length
[mm] |
|------------------|----------------|----------------|----------------|----------------|----------------|
| 3.00 | 9.25 | 11.25 | 12.75 | 14.25 | N/A |
| 3.70 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 4.20 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 4.70 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
| 5.15 | 7.25 | 9.25 | 11.25 | 12.75 | 14.25 |
001_510k_Summary_v4
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for SIC, which features the letters "SIC" in red, sans-serif font, enclosed within a red circle. A small registered trademark symbol (®) is positioned in the upper right quadrant of the circle, slightly above and to the right of the "C" in "SIC". The red color and circular design give the logo a clean and modern appearance.
### 4.3 Compatibility
The FDA-cleared abutments from K173207 are compatible with the above-mentioned SICtapered and SICvantage tapered implants. The SICvantage tapered implants with smallest diameter of Ø3.0 mm are only available to be compatible with FDA-cleared abutments from K173207 with angulation up to 15° under single-unit loading, while the SICtapered and SICvantage tapered dental implants with larger diameter implants (≥ Ø3.7 mm) are compatible with FDA-cleared abutments from K173207 up to 25° angulation under single-unit loading.
#### 5 Indications for Use
### SICtapered
SICtapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICtapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
### Only applicable for SICtapered implants with Ø 3.7 mm
Use without splinting is permissible in the anterior and premolar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
### SICvantage tapered
SICvantage tapered Implants are intended for use during dental implantation and oro-maxillofacial surgery in the bone of the upper and/or lower jaw arches. They provide support for prosthetics, such as artificial teeth, bars or bridges which restore the patient's chewing function. SICvantage tapered Implants are indicated for immediate loading when adequate primary stability is achieved and with appropriate occlusal loading.
### Only applicable for SICvantage tapered implants with Ø 3.0 mm
Use without splinting is permissible in the anterior region for replacement of maxillary and mandibular incisors. In the premolar and molar region, they must be used in rigid combination with other implants. In all cases, they may only be where loads are not extreme.
#### 6 Technological Characteristics
The technological characteristics of SICtapered are the technological characteristics of the predicate device SICmax.
The technological characteristics of SICvantage tapered are the technological characteristics of the predicate device SICvantage max.
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows a red logo with the letters "SIC" in the center. The letters are also red. The logo is a circle, and there is a registered trademark symbol in the upper right corner of the circle. The background is white.
# 6.1 Device Characteristics Table
### SICtapered
| Company | SIC invent AG
(New Device) | SIC invent AG
(Predicate Device) | Result |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Device Name | SICtapered | SICmax | - |
| Regulation Number | 872.3640 | 872.3640 | Same |
| Class | 2 | 2 | Same |
| Code | DZE | DZE | Same |
| 510(k) number | K210489 | K173207 | - |
| Indications for Use | SICtapered Implants are intended for use
during dental implantation and
oromaxillofacial surgery in the bone of the
upper and/or lower jaw arches. They
provide support for prosthetics, such as
artificial teeth, bars or bridges which
restore the patient's chewing function.
SICtapered Implants are indicated for
immediate loading when adequate primary
stability is achieved and with appropriate
occlusal loading.
Only applicable for SICtapered implants
with Ø 3.7 mm
Use without splinting is permissible in the
anterior and premolar region. In the molar
region, they must be used in rigid
combination with other implants. In all
cases, they may only be where loads are
not extreme. | SICmax Implants are intended for use during
dental implantation and oromaxillofacial
surgery in the bone of the upper and/or
lower jaw arches. They provide support for
prosthetics, such as artificial teeth, bars or
bridges which restore the patient's chewing
function. SICmax Implants are indicated for
immediate loading when adequate primary
stability is achieved and with appropriate
occlusal loading.
- Only applicable for SICmax implants with
Ø 3.7 mm
Use without splinting is permissible in the
anterior and premolar region. In the molar
region, they must be used in rigid
combination with other implants. In all
cases, they may only be where loads are not
extreme. | Same |
| Type of Body Contact | Direct | Direct | Same |
| Category of Body Contact | Implant devices | Implant devices | Same |
| Contact of Body Contact | Hard tissues, soft tissues, blood, saliva | Hard tissues, soft tissues, blood, saliva | Same |
| Duration of Body Contact | C - Permanent (>30 d) | C - Permanent (>30 d) | Same |
| Implant Diameter [mm] | 3.70 / 4.20 / 4.70 / 5.15 | 3.70 / 4.20 / 4.70 / 5.15 | Same |
| Implant Length [mm] | 7.25 / 9.25 / 11.25 / 12.75 / 14.25 | 7.50 / 9.50 / 11.50 / 13.00 / 14.50 | Substantially equivalent,
except for 7.25 mm length,
see comparison to K131097
reference device below |
| Implant Connection
[Index] | Inner hexagon | Inner hexagon | Same |
| Index positions | 6 | 6 | Same |
| Size of connection [mm] | HEX 2.30 mm | HEX 2.30 mm | Same |
| Connection height [mm] | 2.2 mm | 2.2 mm | Same |
| Inner thread | M1.6x0.25 | M1.6x0.25 | Same |
| Prosthetic sizes [mm] | 3.3 mm and 4.2 mm | 3.3 mm and 4.2 mm | Same |
| Design | Two-piece | Two-piece | Same |
| Surface Treatment | Sandblasted, Etched | Sandblasted, Etched | Same |
| Material | Titanium Grade 4 (3.7065) | Titanium Grade 4 (3.7065) | Same |
| Delivery Status | Sterile (Irradiation) | Sterile (Irradiation) | Same |
| Company | SIC invent AG
(New Device) | Implant Direct Sybron Manufacturing Llc
(Reference Device 1) | Result |
|-------------------|--------------------------------|-----------------------------------------------------------------|--------|
| Device Name | SICtapered Ø 3.70 mm / 7.25 mm | Legacy3 6mm Length Implants | - |
| Regulation Number | 872.3640 | 872.3640 | Same |
| Class | 2 | 2 | Same |
| Code | DZE | DZE | Same |
{8}------------------------------------------------
# SIC invent AG SICtapered & SICvantage tapered 510(k) Premarket Notification
Image /page/8/Picture/1 description: The image shows a red circle with the letters "SIC" in the center, also in red. A small "R" in a circle is located in the upper right quadrant of the larger circle, indicating a registered trademark. The design is simple and clean, focusing on the acronym within the circular border.
| Company | SIC invent AG
(New Device) | Implant Direct Sybron Manufacturing Llc
(Reference Device 1) | Result |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| 510(k) number | K210489 | K131097 | - |
| Indications for Use | SICtapered Implants are intended for use
during dental implantation and
oromaxillofacial surgery in the bone of the
upper and/or lower jaw arches. They
provide support for prosthetics, such as
artificial teeth, bars or bridges which
restore the patient's chewing function.
SICtapered Implants are indicated for
immediate loading when adequate primary
stability is achieved and with appropriate
occlusal loading.
Only applicable for SICtapered implants
with Ø 3.7 mm
Use without splinting is permissible in the
anterior and premolar region. In the molar
region, they must be used in rigid
combination with other implants. In all
cases, they may only be where loads are
not extreme. | Legacy' 6mm Length consists of two-piece
implants for one-stage or two-stage surgical
procedures. These implants are intended for
use in partially and fully edentulous upper
and lower jaws in support of single or
multiple-unit restorations and terminal or
intermediate abutment support for fixed
bridgework. Implants can be indicated for
immediate loading when good primary
stability has been achieved and with
appropriate occlusal loading. | Substantially
Equivalent |
| Type of Body Contact | Direct | Direct | Same |
| Category of Body Contact | Implant devices | Implant devices | Same |
| Contact of Body Contact | Hard tissues, soft tissues, blood, saliva | Hard tissues, soft tissues, blood, saliva | Same |
| Duration of Body Contact | C - Permanent (>30 d) | C - Permanent (>30 d) | Same |
| Implant Diameter [mm] | 3.70 / 4.20 / 4.70 / 5.15 | 3.70 / 4.20 / 4.70 / 5.20 / 5.70 / 7.00 | Same |
| Implant Length [mm] | 7.25 | 6.00 | Substantially
Equivalent |
| Implant Connection
[Index] | Inner hexagon | Inner hexagon | Same |
| Index positions | 6 | 6 | Same |
| Size of connection [mm] | HEX 2.30 mm | Hex | Substantially
Equivalent |
| Prosthetic sizes [mm] | 3.3 mm and 4.2 | 3.0, 3.5, 4.5, 5.7 | Substantially
equivalent |
| Design | Two-piece | Two-piece | Same |
| Surface Treatment | Sandblasted, Etched | SBM Blasted, HA Coated | Substantially
Equivalent |
| Material | Titanium Grade 4 (3.7065) | Titanium Grade 4 (3.7065)…
---
**Source:** [https://fda.innolitics.com/device/K210489](https://fda.innolitics.com/device/K210489)
**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:** Innolitics at https://innolitics.com