(271 days)
No.
The device description and intended use indicate that this is a physical dental abutment system. There is no mention of software, algorithms, or any AI-related components.
No
The devices are abutments intended to support prosthetic devices (like crowns or bridges) on dental implants, not to provide therapy for a disease or condition. They are structural components for dental restorations.
No
The device, MIST IC abutments, is intended to support prosthetic devices in edentulous patients. It is a restorative component (prosthetic device) and not described as collecting or analyzing patient data for diagnostic purposes.
No
The device is a physical dental abutment made of titanium alloy. It is a hardware medical device designed to interface with dental implants and support prosthetic devices. While there is mention of "digitally designed custom abutments" and "CAD-CAM customized restoration," the device itself is a physical component, and the process described involves a "validated milling center for manufacture" and "milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations." This clearly indicates a physical, manufactured product, not software only.
No
The device is a dental abutment, which is an implantable prosthetic device. It is not used for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
|---|---|---|
| Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC |
| 3.3 | NC | |
| 4.1, 4.8 | RC | |
| Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN |
| 4.8 | WN | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K222368. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate.
Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.
All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.
MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided with engaging and non-engaging connections.
The L-LINK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement required in the labeling (RelyX RMGIP bonding cement, cleared in K022476).
The design parameters for L-LINK patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX L-Link) – 5.0 mm
- Maximum gingival height (for Straumann BLX L-LINK) – 6.0 mm
- Maximum angle – 20°
All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.
MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.
The design parameters for PREFIT patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX PREFIT) – 5.0 mm
- Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm
- Maximum angle – 30°
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, dental laboratory, Imagine Milling Technologies, LLC validated milling center
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 testing data submitted, or relied upon, to demonstrate substantial equivalence included:
-
provided in this submission was non-clinical analysis performed to evaluate the metallic subject devices and the compatible OEM implant bodies in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued October 2023) including magnetically induced displacement force and torque;
-
referenced from K182246 was sterilization validation according to ISO 17665-1 and ISO 17665-2;
-
referenced from K222368 and K182246 was biocompatibility according to ISO 10993-1;
-
shear and tension testing conducted to characterize the mechanical properties of the TiN coated surface as per ASTM F1044 and F1147, respectively.
-
provided in this submission was reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; and
-
provided in this submission was static and dynamic compression-bending testing according to ISO 14801.
No clinical data were included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K162890, K140878, K130222, K173961, K181703, K191256, K210855, K212533, K163194, K180536, K201225
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
Imagine Milling Technologies, LLC
℅ Rebecca Kattan
Regulatory Specialist
PaxMed International, LLC
1925 Palomar Oaks Way
Suite 210
Carlsbad, California 92008
Re: K243009
Trade/Device Name: Mist IC
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
Dated: September 26, 2024
Received: May 23, 2025
June 24, 2025
Dear Rebecca Kattan:
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 (the 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 available 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.
Page 2
June 24, 2025
Imagine Milling Technologies, LLC
℅ Rebecca Kattan
Regulatory Specialist
PaxMed International, LLC
1925 Palomar Oaks Way
Suite 210
Carlsbad, California 92008
Re: K243009
Trade/Device Name: Mist IC
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous Dental Implant Abutment
Regulatory Class: Class II
Product Code: NHA
Dated: September 26, 2024
Received: May 23, 2025
Dear Rebecca Kattan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K243009 - Rebecca Kattan
Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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 -S
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 Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243009
Device Name: MIST IC
Indications for Use (Describe)
MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
|---|---|---|
| Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC |
| 3.3 | NC | |
| 4.1, 4.8 | RC | |
| Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN |
| 4.8 | WN | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.
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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services(301) 443-6740 EF
Page 6 of 6
K243009
Page 5
510(k) Summary MIST IC
Page 1 of 8
K243009
510(k) Summary
K243009
MIST IC
Imagine Milling Technologies, LLC
June 20, 2025
ADMINISTRATIVE INFORMATION
Manufacturer Name: Imagine Milling Technologies, LLC
14220 Sullyfield Circle, Suite B
Chantilly, VA 20151
Telephone +1 888-635-4999
Official Contact: Felix Chung, CEO
Representative/Consultant: Rebecca E. Kattan, PhD
Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
1925 Palomar Oaks Way, Suite 210
Carlsbad, CA 92008
Telephone +1 858-792-1235
Email rkattan@paxmed.com
kthomas@paxmed.com
flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: MIST IC
Common Name: Dental implant abutment
Regulation Number: 21 CFR 872.3630
Regulation Name: Endosseous dental implant abutment
Regulatory Class: Class II
Product Code: NHA
Classification Panel: Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices)
Reviewing Division: Division of Dental and ENT Devices
PREDICATE AND REFERENCE DEVICE INFORMATION
K222368, MIST IC, Imagine Milling Technologies, LLC
K240208, DESS Dental Smart Solutions, Terrats Medical SL
K182246, MIST IC, Imagine Milling Technologies, LLC
Reference Devices for OEM implant body clearances:
K162890, Straumann Ø2.9 mm Bone Level Tapered Implants, SC Closure Cap, SC Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutments, Straumann USA, LLC
K140878, Straumann® Bone Level Tapered Implants, Straumann USA, LLC
K130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, LLC
K173961, Straumann® BLX Implant System, Institut Straumann AG
Page 6
510(k) Summary
Page 2 of 8
MIST IC K243009
K181703, Straumann® BLX Line Extension – Implants, SRAs and Anatomic Abutments, Institut Straumann AG
K191256, Straumann BLX Ø3.5 mm Implants, Institut Straumann AG
K210855, Straumann BLX Implant System, Institut Straumann AG
K212533, BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants, Institut Straumann AG
K163194, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários SA
K180536, Neodent Implant System – GM Line, JJGC Indústria e Comércio de Materiais Dentários S.A.
K201225, Neodent Implant System – GM Helix Implants 7.0, JJGC Indústria e Comércio de Materiais Dentários S.A.
The primary predicate device is K222368.
The reference device K240208 is for support of substantial equivalence of the range of prosthetic platform diameters and gingival height for the subject device L-LINK (Ti base) and PREFIT (blank) abutments. The reference device K182246 is included for leveraging of sterilization validation and biocompatibility.
INDICATIONS FOR USE STATEMENT
MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement-retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants:
| Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
|---|---|---|
| Straumann Bone Level (CrossFit® Morse Taper) | 2.9 | SC |
| 3.3 | NC | |
| 4.1, 4.8 | RC | |
| Straumann® Tissue Level (CrossFit® Connection) | 3.3, 4.1, 4.8 | RN |
| 4.8 | WN | |
| Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5 | RB |
| 5.0, 5.5, 6.5 | WB | |
| Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.
SUBJECT DEVICE DESCRIPTION
MIST IC from Imagine Milling Technologies, LLC is a line of Ti-base and machinable blank abutments to interface with compatible dental implants from four (4) manufacturers, and a total of eight (8) implant-abutment interface compatibilities. The subject device prosthetic platform diameters range from 3.8 mm to 6.9 mm. All stock subject device components (abutments and abutment screws) are made of titanium alloy conforming to ASTM F136. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the process used for TiN coating of Imagine Milling Technologies, LLC devices cleared in K222368. The PVD cathodic arc evaporation process is a high current, low voltage process in which material evaporated from the cathode (Ti) is ionized, transported through the vacuum chamber with reactive gas (N2) and deposited as a non-porous, thin film on the titanium substrate.
Page 7
510(k) Summary
Page 3 of 8
MIST IC K243009
Each abutment is supplied with the non-sterile abutment screw designed for attachment to the corresponding compatible OEM implant.
All patient-specific abutment fabrication for all MIST IC abutments is by prescription on the order of the clinician. All MIST IC abutments are intended to be milled at an Imagine Milling Technologies, LLC validated milling center under FDA quality system regulations.
MIST IC L-LINK abutments are two-piece abutments to be used as a base when fabricating a CAD-CAM customized restoration where the superstructure produced will compose the second part of the two-piece abutment; the assembly becoming a final finished medical device after cementation on the subject device abutment. They are provided with engaging and non-engaging connections.
The L-LINK abutments and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory, or separately for the clinician to bond together chairside using the cement required in the labeling (RelyX RMGIP bonding cement, cleared in K022476).
The design parameters for L-LINK patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX L-Link) – 5.0 mm
- Maximum gingival height (for Straumann BLX L-LINK) – 6.0 mm
- Maximum angle – 20°
All zirconia copings (superstructures) for use with the subject device MIST IC L-LINK abutments will conform to ISO 13356.
MIST IC PREFIT abutments are cylindrical abutments designed for patient-specific abutment fabrication by a CAD-CAM process and machined into a one-piece, all titanium abutment. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. MIST IC PREFIT abutments have an engaging connection.
The design parameters for PREFIT patient-specific abutments are:
- Minimum wall thickness – 0.5 mm
- Minimum cementable post height for single-unit restoration – 4.0 (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
- Minimum gingival height – 0.5 mm
- Maximum gingival height (for all except Straumann BLX PREFIT) – 5.0 mm
- Maximum gingival height (for Straumann BLX PREFIT) – 6.0 mm
- Maximum angle – 30°
PERFORMANCE DATA
Non-clinical testing data submitted, or relied upon, to demonstrate substantial equivalence included:
Page 8
510(k) Summary
Page 4 of 8
MIST IC K243009
-
provided in this submission was non-clinical analysis performed to evaluate the metallic subject devices and the compatible OEM implant bodies in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, and S Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued October 2023) including magnetically induced displacement force and torque;
-
referenced from K182246 was sterilization validation according to ISO 17665-1 and ISO 17665-2;
-
referenced from K222368 and K182246 was biocompatibility according to ISO 10993-1;
-
shear and tension testing conducted to characterize the mechanical properties of the TiN coated surface as per ASTM F1044 and F1147, respectively.
-
provided in this submission was reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility; and
-
provided in this submission was static and dynamic compression-bending testing according to ISO 14801.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device K222368. The subject device, the primary predicate device K222368, and the reference device K182246 are intended to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. Provided at the end of this summary is a table comparing the Indications for Use Statements (IFUS) and the technological characteristics of the subject device, the primary predicate device K222368, and the reference device K182246.
All additional reference devices are identified for OEM implant body compatibilities.
The IFUS for the subject device is similar to that of the primary predicate device K222368. The only differences in language of the subject device and primary predicate device are limited to the compatible implant systems and, therefore, do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function. The IFUS for the subject device also is very similar to that of the reference device K240208. The minor differences in the reference device IFUS are the specific language and the list of compatible implant systems, and these differences do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function.
The subject device abutments and the abutments cleared in the primary predicate device K222368 are indicated for use with CAD-CAM technology to fabricate patient-specific abutments prescribed by the clinician. The subject device and the primary predicate device require that digital files for CAD-CAM fabricated abutments be sent to an Imagine Milling Technologies, LLC validated milling center for manufacture.
The subject device L-LINK (Ti base) abutments are substantially equivalent to the L-LINK abutments cleared in the primary predicate K222368 in material, design, and function. Both are manufactured from titanium alloy (conforming to ASTM F136) with a titanium nitride (TiN) coating, both base designs require a zirconia superstructure that is cement-retained only, and both have the same range of angulation (up to 20°).
The subject device MIST IC L-LINK abutments differ from the L-LINK abutments cleared in the primary predicate K222368 in the range of prosthetic platform diameters, the maximum gingival height in the zirconia superstructure, and the abutment-implant interfaces. The ranges of prosthetic platform diameters and the
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maximum gingival height in the zirconia superstructure for the subject device are within those of the reference device K240208. These differences do not impact safety or effectiveness because they are related to the compatible OEM implant designs and are mitigated by testing of the subject device constructs in conformance with ISO 14801.
The subject device PREFIT abutments are substantially equivalent to PREFIT abutments cleared in the primary predicate K222368 in material, design, and function. Both are for cement-retained, single-unit or multi-unit restorations, are manufactured from titanium alloy (conforming to ASTM F136), and are for CAD-CAM fabrication of a one-piece, patient-specific abutment. The subject device PREFIT abutments and the PREFIT abutments cleared in K222368 have the same range of angulation (up to 30°) and gingival height (up to 6 mm). The subject device MIST IC PREFIT differs from the primary predicate K182246 MIST IC PREFIT in the range of platform diameters and abutment-implant interfaces. These differences do not impact safety or effectiveness because they are related to the compatible OEM implant designs and are mitigated by testing of the subject device constructs in conformance with ISO 14801.
The subject device MIST IC L-LINK and MIST IC PREFIT stock abutments are made of titanium alloy conforming to ASTM F136. The titanium alloy subject device components are manufactured from identical materials, in identical facilities using the identical manufacturing processes used for Imagine Milling Technologies, LLC products cleared previously in K222368. The subject device MIST IC L-LINK abutments have a TiN coating achieved through a physical vapor deposition (PVD) process that is identical to the TiN coating on devices previously cleared in Imagine Milling Technologies, LLC primary predicate K222368. No dyes or coloring additives are used.
The subject device MIST IC L-LINK abutments are to be used with copings fabricated from zirconia conforming to ISO 13356. This is the same material used for copings in the primary predicate device K222368. The required bonding cement for the subject device MIST IC L-LINK zirconia superstructures is RelyX RMGIP cleared in K022476, the same cement required for bonding the copings in the primary predicate device K222368.
Compatibility testing was performed for each of the compatible OEM implant system interfaces (platforms). For each of the compatible OEM implant system interfaces, critical dimensions were identified and were measured from samples of OEM implants, OEM abutments, and OEM abutment screws. The key dimensional data measured from the OEM components were used to establish tolerances for corresponding subject device abutments and abutment screws to ensure that the subject device components are compatible with the corresponding OEM implant system connections.
Mechanical performance testing of the subject device was performed in conformance to ISO 14801. The fatigue limit data demonstrated that constructs of the subject device abutments and abutment screws, fabricated to the limits stated in the proposed labeling, in combination with previously cleared compatible OEM implants have sufficient strength for their intended use.
Minor differences in the designs, dimensions, sizes, or compatible implant lines between the subject device and the primary predicate device do not affect substantial equivalence. These minor differences do not impact substantial equivalence because these differences are related to the compatible OEM implant designs.
CONCLUSION
The subject device has the same intended use, have similar technological characteristics, and are made of the same materials as the primary predicate device and reference device. The subject device encompass the same range of physical dimensions, are packaged in the same materials, and are to be sterilized using the same
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methods as the primary predicate device and reference device. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
The basis for the belief of Imagine Milling Technologies, LLC that the subject device is substantially equivalent to the predicate device and reference device is summarized in the following Table of Substantial Equivalence.
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Table of Substantial Equivalence
| Features | Subject Device K243009 MIST IC Imagine Milling Technologies, LLC | Primary Predicate Device K222368 MIST IC Imagine Milling Technologies, LLC | Reference Device K240208 DESS Dental Smart Solutions Terrats Medical SL |
|---|---|---|---|
| Representative image, not to scale | [Image] | [Image] | |
| Indications for Use Statement | MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants: Compatible Implant Systems All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture. | MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single unit or multi-unit, cement retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants: Compatible Implant Systems All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture. MIST IC abutments for Biomet 3i Certain are indicated for maxillary lateral and mandibular central/lateral incisors only. | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. All digitally designed custom abutments for use with DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems |
| Reason for Predicate Device | Not applicable | Abutment designs, materials, manufacturing, sterilization | Abutment designs |
| Product Code | NHA | NHA | NHA |
| Designs | |||
| Abutment Designs | CAD-CAM Titanium Base (L-LINK) CAD-CAM Titanium Blank (PREFIT) | CAD-CAM Titanium Base (L-LINK) CAD-CAM Titanium Blank (PREFIT) | Various, including Titanium Base and Titanium Blank abutments |
| Restoration | Single-Unit Multi-Unit | Single-Unit Multi-Unit | Single-Unit Multi-Unit |
| Prosthesis Attachment | Cement-retained | Cement-retained | Cement-retained |
| Abutment/Implant Interface | Internal | Internal | Various |
| L-LINK Titanium Base Abutments | |||
| Post Height (length above gingival height), mm | 4.7- 5.5 | 3.8- 5.3 | 3.0- 4.2 |
| Prosthetic platform diameter, mm | 3.8 – 6.9 | 3.4 – 6.0 | 3.5 – 7.0 |
| Design Parameters for Zirconia Superstructure | |||
| Minimum wall thickness, mm | 0.5 | 0.5 | 0.4 |
| Minimum post height for single-unit restoration, mm | 4.0 | 4.0 | 4.20 |
| Minimum gingival height, mm | 0 (all bases have minimum gingival height of 0.5 mm) | 0 (all bases have minimum gingival height of 0.5 mm) | 0 (all bases have minimum gingival height of 0.3 mm) |
| Maximum gingival height, mm | 6.0 | 5.0 | 6.0 |
| Angulation | Up to 20° | Up to 20° | Up to 30° |
| Required Cement to bond superstructure to base | 3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP | 3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP | Multi-Link cement, Ivoclar Vivadent |
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| Features | Subject Device K243009 MIST IC Imagine Milling Technologies, LLC | Primary Predicate Device K222368 MIST IC Imagine Milling Technologies, LLC | Reference Device K240208 DESS Dental Smart Solutions Terrats Medical SL |
|---|---|---|---|
| PREFIT Blank Abutment – Finished Design Parameters | |||
| Minimum wall thickness, mm | 0.5 | 0.5 | 0.45 |
| Minimum post height for single-unit restoration, mm | 4.0 | 4.0 | 4.0 |
| Minimum gingival height, mm | 0.5 | 0.5 | 0.5 |
| Maximum gingival height, mm | 6.0 | 5.0 | 6.0 |
| Angulation | Up to 30° | Up to 30° | Up to 30° |
| Materials | |||
| Abutments | Titanium Alloy (ASTM F136) Zirconia, copings (ISO 13356) | Titanium Alloy (ASTM F136) Zirconia, copings (ISO 13356) | Titanium Alloy (ASTM F136) Co-Cr-Mo Alloy (F1537) Zirconia, copings (ISO 13356) |
| Abutment Surface | TiN coating (Ti Bases) | TiN coating (Ti Bases) | SelectGrip® surface Zirconium nitride (ZrN) |
| Screws | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) | Titanium Alloy (ASTM F136) |
| How Provided | |||
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile |
| Sterilization Method | Moist Heat | Moist Heat | Moist Heat |
| Usage | Single patient, single-use | Single patient, single-use | Single patient, single use |