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Found 7877 results
510(k) Data Aggregation
(258 days)
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(53 days)
HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML, HTP-plus, STP, STP-C, STP-ML, SHTP, SHTP-C, SHTP-ML, 3DP-Pro-ML are indicated for the treatment of partial or total loss of anatomical crown in the anterior and posterior tooth regions, from single crown to up to 14-unit teeth, i.e. the manufacturing of
- anatomically reduced and fully anatomical (monolithic) crowns in the anterior and posterior tooth range (e.g. single-tooth crowns, inlays, onlays, veneers);
- anatomically reduced and fully anatomical (monolithic) bridges (up to 14 units) in the anterior and posterior tooth range.
UT, UT-C, UT-ML, UTP, UTP-C, UTP-ML are indicated for the treatment of partial or total loss of anatomical crown in the anterior and posterior tooth regions, from single crown to up to 3-unit teeth, i.e. the manufacturing of
- anatomically reduced and fully anatomical (monolithic) crowns in the anterior and posterior tooth range (e.g. single-tooth crowns, inlays, onlays, veneers);
- anatomically reduced and fully anatomical (monolithic) bridges (up to 3 units) in the anterior and posterior tooth range.
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is composed of yttria-stabilized zirconia. The yttria-stabilized zirconia has a long history of safe use in dentistry.
Bloomden Dental Zirconia Blank is white, and it is composed of ZrO₂ + HfO₂ + Y₂O₃ and additional other oxides. Bloomden Dental Zirconia Pre-Shaded Blank is color (containing 20 available Vita shades), and it contains not only the ingredients same as the white zirconia blank but also very small amount of additional inorganic pigments (Fe₂O₃, Er₂O₃, MnO/Co₃O₄). The inorganic pigments generate the color on the restorations, after sintering in dental labs, matching natural color of patient's teeth. And there are two color representations (i.e. monolayer and multilayer) for the color zirconia blank.
The proposed device is provided in various translucency. It also offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays, based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method.
The performance of the proposed device conforms to ISO 6872:2024 Dentistry - Ceramic Materials.
The proposed device is a single-use device, and provided non-sterile. The shelf life is 5 years.
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(88 days)
CyClean Cord is knitted retraction cord made from 100% lyocell, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.
The CyClean Cord is a dental gingival retraction cord containing aluminum chloride Hexahydrate in 100% lyocell knitted yarn, and is used to temporarily retract gingival tissue prior to obtaining a dental impression, and at the same time remove blood, saliva, and gingival fluid remaining in the gingival hotspots.
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(266 days)
The Adin Long Dental Implant System is intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices such as artificial teeth in order to restore the patient's chewing function in fully or partially edentulous patients. The implants are intended for multi-unit, full-arch, screw-retained prosthetic restorations and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Adin Touareg-OS Zygomatic Dental Implants are intended for placement in the zygomatic bone in patients with severe atrophic maxilla; they may be used with implant-level framework designs with 45° to 60° angulation.
Adin Long Dental Implant System is an extension of previously cleared dental implant devices, designed to expand the product offering and provide additional options for dental restoration procedures. Specifically, this submission seeks marketing clearance for the following implants and abutments:
(1) Adin TouaregTM-OS Zygomatic Dental Implants:
- Outer diameter of 4.2 mm
- Available Lengths: 35.0mm, 37.5mm, 40.0mm, 42.5mm, 47.5mm, 50.0mm, 52.5mm and 55.0mm.
(2) Adin Long Dental Implant System -RS TMATM:
- Connection: RS
- Diameter: 4.9 mm
- Available Configurations (Angle / Gingival Height):
- 45° / 4 mm
- 52° / 5 mm
- 60° / 5 mm
ADIN TOUAREGTM-OS ZYGOMATIC DENTAL IMPLANTS:
Adin TouaregTM-OS Zygomatic dental implants is a threaded, root-form dental implants made of biocompatible Ti-6Al-4V ELI alloy complying with ASTM F136-13(2021)e1 – "Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications" and ISO 5832-3:2021 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".
Adin TouaregTM-OS Zygomatic Dental Implants are used for surgical placement through the maxillary arch and anchored in the zygomatic bone to provide support for prosthetic devices such as artificial teeth to restore the patient's chewing function in edentulous or partially edentulous patients only with severe atrophic maxilla.
Adin TouaregTM-OS Zygomatic Dental Implants are intended for extra-maxillary extra-sinus procedures, and their use is limited to ZAGA-4 extra-maxillary implant placement.
The device is intended to be used under the following clinical conditions and surgical parameters:
- Multi-unit reconstruction (TMA), with a rigid splinting of minimum two implants.
- For an edentulous/full mouth restoration, should be used together with at least two standard implants.
- It should be used only in patients with severe atrophic maxilla.
- Extra-maxillary extra-sinus procedures intended to be anchored in the zygoma bone
- One stage or two stage surgical operation.
- Immediate loading (function) is applicable provided that stability requirements are satisfied.
All TouaregTM-OS Zygomatic implants have OsseoFixTM surface treatment which was previously cleared under Adin's 510(k) K212775 for Adin's legally marketed Adin Short Implants and remained unchanged since these clearances.
ADIN TOUAREGTM-OS ZYGOMATIC IMPLANTS – RS TMATM
The TMATM system is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.
Adin TouaregTM-OS Zygomatic implants are intended for TMA in combination with a rigid splinting of a minimum of 2 conventional dental implants.
Screw-retained abutments are made of titanium alloy 6Al-4V ELI complying with ASTM F136-13 and ISO 5832-3:2021 - Implants for surgery — Metallic materials — Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
The TMA system is used to elevate seating platform of restoration when restoration at implant level is not indicated or practical due to the depth or emergence angle of the implant.
The Adin TouaregTM-OS Zygomatic Implants - RS Angled TMATM (45°, 52°, 60°) are only intended for use with the proposed Adin TouaregTM-OS Zygomatic Dental Implants.
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(214 days)
Bifix Veneer LC:
Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.)
Bifix Veneer Try-In:
For selection of the shade of Bifix Veneer LC for the subsequent permanent luting of the restoration.
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(90 days)
- Indicated for bite registration in prosthodontics, orthodontics, and implantology.
- Used for recording the occlusal relationship to aid in the fabrication of crowns, bridges, dentures, and orthodontic appliances.
- Suitable of occlusal analysis and adjustment in clinical dental procedures.
Dia-X Sil Bite is vinyl polysiloxane (VPS) – based bite registration material designed for occlusal capture. Classified as Type B under ISO 4823 standards.
No. Model Name Composition
1 Dia-X Sil Bite A Type Dia-X Sil Bite 50ml Cartridge 1ea
2 Dia-X Sil Bite C Type Dia-X Sil Bite 50ml Cartridge 2ea
3 Dia-X Sil Bite E Type Dia-X Sil Bite 50ml Cartridge 4ea + Mixing Tip 10ea
4 Dia-X Sil Bite G type Dia-X Sil Bite 50ml Cartridge 10ea
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(5 days)
APAPRO Desensitizer Homecare is a fluoride-free daily-use cleaning toothpaste that also provides relief from tooth sensitivity due to cold, heat, acids, sweets or contact, through its action of occluding dentin tubules through surface coating, promoting an environment conducive to remineralization.
APAPRO Desensitizer Homecare is a fluoride-free daily-use toothpaste device that contains hydroxyapatite, the main component of teeth, as its active ingredient. The formulation is designed to clean teeth as well as to help restore a tooth's hydroxyapatite structure through surface coating, promoting an environment conducive to remineralization, which results in physical occlusion of exposed dentin tubules, providing relief from tooth hypersensitivity. The hydroxyapatite deposited into the dentin tubules by APAPRO Desensitizer Homecare acts as a template for the further deposition of large amounts of calcium and phosphate ions, promoting crystal integrity and growth.
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(267 days)
The EnCore Impression Material is intended for dental impression techniques to reproduce the structure of a patient's dentition to fabricate patient matched night guards and mouthguards.
The EnCore Impression Material is an addition-cure impression material composed of vinyl polysiloxane impression and bite registration materials intended to allow dentists to take accurate impressions.
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(167 days)
ZENEX Implant System_Short(R-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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture system is intended to be used in the molar region.
Short and Wide implants must be splinted to adjacent implants in areas of poor bone quality or high occlusal forces.
ZENEX Implant System_Short (R-System) is a thread type implant made of pure titanium according to ASTM F67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost.
The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The entire length of 6.25mm of implant bodies are implanted into the bone to connect prosthetic devices of a dental implant set with the human body (mandibular or maxillary bone).
There is a type of fixture, and the dimensions are as follows:
| Name | Fixture Type | Diameter (mm) | Length (mm) | Material |
|---|---|---|---|---|
| ZENEX Implant System_Short (R-System) | ∅ 5.05/5.4/5.9/6.75 | 6.25 | Ti CP4 (ASTM F67) |
Tolerance of dimension shall be within ± 1% range.
The subject devices are compatible with the following abutments made by Izenimplant Co., Ltd.
| K number | Abutment Name | Diameter (∅) | Angulation | Length or Cuff(mm) | Material + Surface Treatment |
|---|---|---|---|---|---|
| K252585 | Cover Screw | ∅3.5 | 0˚ | P/H: 0.4/1.4/2.0 | Ti-6Al-4V ELI |
| Healing Abutment | ∅4.2/5.2/6.2/7.2/8.0/9.0 | 0˚ | P/H: 3/4/5/6/7/9 | Ti-6Al-4V ELI | |
| Cemented Abutment | ∅4.0/5.0/6.0/7.0 | 0˚ | G/H: 1.8/2.8/3.8/4.8, PH: 5.5/7 | Ti-6Al-4V ELI + TiN Coating | |
| Angled Abutment | ∅4.0/5.0/6.0/7.0 | 15˚/25˚ | G/H: 1.8/2.8/3.8/4.8, P/H: 7 | Ti-6Al-4V ELI + TiN Coating | |
| Temporary Abutment | ∅4.0 | 0˚ | G/H: 0.8/2.8, P/H: 10 | Ti-6Al-4V ELI | |
| Ball Abutment | ∅3.5 | 0˚ | G/H: 0.8/1.8/2.8/3.8/4.8/5.8 | Ti-6Al-4V ELI | |
| Multi Abutment | ∅4.8 | 0˚/17˚/30˚ | G/H: 1.3/2.3/3.3/4.3 | Ti-6Al-4V ELI | |
| CCM Cast Abutment | ∅4.0 | 0˚ | G/H: 0.8/2.8, P/H: 10 | Co-Cr-Mo Alloy | |
| FreeMilling Abutment | ∅4.0/5.0/6.0/7.0 | 0˚ | G/H: 1.8/2.8/3.8/4.8, P/H: 9 | Ti-6Al-4V ELI + TiN Coating | |
| Abutment Screw | ∅2.1 | 0˚ | 7.7 | Ti-6Al-4V ELI | |
| Multi Angled Abutment Screw | ∅2.05 | 0˚ | 6.75 | Ti-6Al-4V ELI |
Fixture is provided sterile, and valid for 5 years.
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(1 days)
Venus Bulk Flow One
- Class I, II, III, IV and V direct restorations
- First-layer lining for class I and II cavities
- Repair of direct and indirect restorations in combination with a suitable adhesive
- Splinting of teeth
- Extended fissure sealing
- Composite attachments for aligner treatment
- Fixation of retainers
Venus Diamond Flow
- Enlarged fissure sealing
- Cavity lining – as the first layer for Class I and II cavities
- Class I, II, III, IV and V direct restorations
- Small repairs of direct and indirect restorations combined with a suitable bonding agent
- Splinting of teeth
- Composite attachments for aligner treatment
- Fixation of retainers
Venus Diamond
- Direct restorations of all cavity classes
- Direct composite veneers
- Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.)
- Splinting of teeth
- Restoration of primary teeth
- Core build-up
- Repairs of porcelain, composite (in combination with an adequate repair-system)
- Composite attachments for aligner treatment
- Fixation of retainers
Venus Pearl
- Direct restorations of all cavity classes
- Direct composite veneers
- Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.)
- Splinting of teeth
- Restoration of primary teeth
- Core build-up
- Repairs of porcelain, composite (in combination with an adequate repair-system)
- Composite attachments for aligner treatment
- Fixation of retainers
All four devices are light-curing, radiopaque, polymer-based dental composites (nano/nanohybrid) supplied in syringes and PLT units for professional use. They are applied in thin layers and polymerized using dental curing lights (typ. 450–480 nm; ~600–1550 mW/cm²). Packaging sizes and handling characteristics (viscosity/flow for the "Flow" and "Bulk Flow" variants; modeling characteristics for "Diamond" and "Pearl") align with their intended use in direct restorations and related clinical procedures, including aligner attachment fabrication and retainer fixation.
Representative compositions include inorganic fillers (e.g., barium alumino-borosilicate glass, silica, ytterbium fluoride), dimethacrylate resins (e.g., UDMA, TEGDMA, TCD-urethaneacrylate, E4BADMA), initiators (e.g., camphorquinone), stabilizers (e.g., BHT), and pigments/fluorescent agents. Radiopacity meets ISO 4049 acceptance criteria and is within the enamel/dentin-relevant ranges reported for each product.
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