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ChecQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

The ChecQ is a dental implant stability analyzer comprising a main unit and a charging cradle that uses Resonance Frequency Analysis (RFA) to measure implant stability non-invasively. It works with the ChecQPEG, which attaches to the dental implant, and measures stability by analyzing resonant frequencies generated by magnetic field stimulation from the probe tip. The stability result is displayed on the main unit's screen as an Implant Stability Quotient (ISQ), ranging from 1 to 99. The RFA method evaluates by applying transverse force to the implant using magnetism, measuring movement, and analyzing the resulting resonance frequency. The resonance frequency depends on the bone-implant gap and is calculated using a formula, with values expressed as ISQ scores (1-99) for clinical interpretation. The ChecQ mechanism converts voltage pulses generated by the DAC of the MCU into magnetic pulses, which induce vibrations in the ChecQPEG magnets. The device captures the free vibrations as magnetic pulses, processes them through an FFT to extract the natural frequency, and calculates the ISQ value based on this frequency.

Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

The Luvis Chair (LC700C) includes a chair used by dentists to provide seating for patients during dental procedures. It is designed to position the patient during treatment. The chair consists of a seat, backrest, and armrests that can be adjusted to accommodate the patient's position. Additionally, it may feature a headrest to offer additional support. Dental unit chairs come equipped with various tools and attachments, including dental lights, suction devices, and air- water syringes. The chair's controls are usually located within reach of the dentist, allowing for quick adjustments during the procedure. The Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories.

Dentis s-Clean SQ-SL Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). The dimensions of fixtures are as following: | No. | Device Name | Dimension Ranges | |-----|----------------------------|------------------------------------------| | 1 | s-Clean SQ-SL Fixture | Ø4.35, 4.8 and 5.2 (D) X 15.5 and 17.5mm | | 2 | s-Clean SQ-SL Fixture Mini | Ø3.7 and 4.1 (D) X 15.5 and 17.5 | Tolerance of dimension shall be within ± 1% range. s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below: | 510(K) | Abutment Name | Diameter(Ø) | Angulation | Length(mm) | |---------|---------------------------------------------------|---------------------------|------------|---------------------| | K192688 | s-Clean Cover Screw | Ø3.6mm | 0 | 5.9mm | | K192688 | s-Clen (TiN Half Coating)<br>Sole Abutment S-Line | Ø4.5, 5.5, 6.5 and<br>7.5 | 0 | 11.6, 12.6 and 13.6 | | K210134 | s-Celan (TiN Half Coating)<br>Angled Abutment | Ø4.5 | 15 | 12.6 | s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below: | 510(K) | Abutment Name | Diameter(Ø) | Angulation | Length(mm) | |---------|----------------------------------------------------|-------------------|------------|---------------------------------------------------------------------------------------------------------------------------| | K210080 | s-Clean Cover Screw Mini | Ø3.2mm | 0 | 5.0mm | | K2100080 | s-Clean Healing Abutment S-<br>Line Mini | Ø4.3, 4.8 and 5.8 | 0 | 7.61, 8.61, 9.61, 10.61, 11.61,<br>12.61 and 14.61 | | K210080 | s-Celan (TiN Half Coating)<br>Sole Abutment Mini | Ø4.5 and 5.5 | 0 | 11.01, 12.01, 12.51, 13.01,<br>13.521, 14.01, 14.51, 15.01,<br>15.51, 16.01 and 17.01 | | K210080 | s-Celan (TiN Half Coating)<br>Couple Abutment Mini | Ø4.0, 4.5 and 5.5 | 0 | 8.35, 8.6, 9.35, 9.6, 9.85, 10.1,<br>10.35, 10.6, 11.1, 11.35, 11.6,<br>12.1, 12.85, 13.1, 13.35, 13.6,<br>14.35 and 14.6 | | K210080 | s-Celan (TiN Half Coating)<br>Angled Abutment Mini | Ø4.0 and 4.5 | 15 | 12.09, 12.34, 12.51 and 12.76 | Denis s-Clean SQ-SL Fixture is provided sterilized. Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

Dentis i-Clean System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis i-Clean system is intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment screws.

The Dentis s-Clean SQ-SL Narrow Implant System is intended for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The Dentis s-Clean SQ-SL Narrow Implant System is limited to the replacement of maxillary lateral incisors and mandibular incisors. It is intended for delayed loading. The Dentis s-Clean SQ-SL Narrow Implant System may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implants may be restored immediately 1) with a temporary prosthesis that is not in functional occlusion, 2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or 3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The Dentis s-Clean SQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal connection, intended for single use. Dentis s-Clean SQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implant is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.

s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors. s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow are intended to be manufactured at a Dentis validated milling center.

The s-Clean Link Abutment Narrow is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of a two-piece abutment that is a link abutment at the bottom and a coping (CAD/CAM patient specific superstructure) as the top-half. The submission also includes an abutment fixation screw. The s-Clean Link Abutment are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The top half of the s-Clean link abutment composed of zirconia is referenced from our previously cleared K222913 submission. s-Clean Abutment Screw is made of Ti-6Al-4V ELI (ASTM F136) and cleared in K161244. The diameters of s-Clean Link Abutment Narrow are 4.0 and 4.5mm. s-Clean Link Abutment Narrow is provided non-sterile and must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment Narrow.

Dentis I-FIX Abutment is intended for use as an aid in prosthetic rehabilitation.

Dentis I-FIX Abutment consists of I-FIX Angled Type Fixture Healing Abutment, I-FIX Angled Type Fixture Healing Abutment Screw, and I-FIX Abutment Screw. I-FIX Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are compatible with following Implant Systems: Proprietary Name: I-FIX System (Angled Type Fixture) Compatible Implants (K number): K083586 Implant diameter size: Ø 2.0, 2.5, 3.0 mm Implant length: 10~16 mm I-FIX Abutment Screw is only used with I-FIX Cemented Abutment and I-FIX Free Abutment cleared in K083586. The dimensions of abutments are as following: 1. I-FIX Angled Type Fixture Healing Abutment: (D) 4.03 X (L) 3.2, 4, 5 and 7 mm, Angulation 0° 2. I-FIX Angled Type Fixture Healing Abutment Screw: (D) 2.15 X (L) 4.0, 4.8, 6.1 and 8.0 mm, Angulation 0° 3. I-FIX Abutment Screw: (D) 2.15 X (L) 4.7 mm, Angulation 0° Tolerance of dimension for Abutments shall be within ± 1% range. The Abutments have below featured: - I-FIX Angled Type Fixture Healing Abutment: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Titanium Grade 4. - I-FIX Angled Type Fixture Healing Abutment Screw: Uses - The healing Abutment is used for protecting inner hole of fixture and adjusting the appropriate height during the healing period. Surface - Non. Materials - Ti-6Al-4V ELI. - I-FIX Abutment Screw: Uses - I-FIX Abutment screw is used with the previously cleared devices, K083586 such as I-FIX Cemented and Free Abutment for connecting with fixture. Surface - Non. Materials - Ti-6Al-4V ELI. I-Fix Angled Type Fixture Healing Abutment and I-FIX Angled Type Fixture Healing Abutment Screw are packaged as a set and provided sterilized. I-FIX Abutment Screw is provided non-sterilized. Materials: - I-FIX Angled Type Fixture Healing Abutment is fabricated from pure titanium (Conforming to ASTM Standard F67) - I-FIX Angled Type Fixture Healing Abutment Screw and I-FIX Abutment Screw are fabricated from Ti-6Al-4V ELI (Conforming to ASTM Standard F136)

The device is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.

SAVE GBR is manufactured by Ti-6Al-4V ELI. The SAVE GBR is composed of GBR Screw and Bone Tack and these screws and tacks are used to fix barrier membranes in bone regeneration procedures. The diameter of the GBR screw is 1.4 and length is 3.9, 4.38, 5.9, 6.38, 7.9 and 8.38mm. The diameter of the Bone Tack is 2.5 and length is 2.6 and 4.1mm. These screws and tacks are implanted for a maximum duration of 6 months. The SAVE GBR is provided sterile. The subject device is compatible with the OssBuilder membrane cleared in K172354.

SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dentoalveolar bony defect sites.

The SAVE GBR consists of Healing Cap, Cover Cap and Spacer. The SAVE GBR are manufactured by Ti-6A1-4V ELI and used with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites. The subject device is compatible with the OssBuilder membrane cleared in K172354. The dimension of the device is as below: | No. | Product | Diameter | Length | |-----|-------------|--------------|---------------| | 1 | Healing Cap | Ø4.5 and 5.5 | 6.0 and 7.0mm | | 2 | Cover Cap | Ø4.5 | 4.0mm | | 3 | Spacer | Ø4.5 | 7.2 and 8.2mm | The healing cap and cover cap have same functions and uses but have different design and name. The SAVE GBR are removed from the patient after such time when sufficient bone regeneration is done.