(196 days)
The Contour Healer Temporary Abutment is intended for use with a root-form endosseous dental abutment to aid in prosthetic rehabilitation. The abutment is a provisional restoration that aids in creating an esthetic emergence through the gingiva during the healing period. The device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed.
These abutments are designed to work with the following implant systems:
Zimmer [Screw-Vent Dental Implant System]
Nobel Biocare [Replace HA Coated Implant, Replace TiUnite Endosseous Impiant, Nobel Biocare Endosseous Implants, and Groovy Implants]
BioHorizons [BioHorizons·Tapered Internal Implant System].
The Contour Healer. LLC product line includes pre-manufactured dental abutments intended to serve as a temporary dental prosthesis during the healing process until a permanent crown is fabricated. The abutment is made of PEEK Classix and is directly connected to the endosseous dental abutment by a stainless steel screw.
These abutments have biconvex domes to mimic emergence of the original tooth morphology. and therefore provide for a more esthetic gingival contour during the restorative phase. The abutments come in several abutment- to-implant diameters. The abutments are intended for single-use not to exceedninety days. At the end of the treatment period, the temporary abutment is to be removed by clinician and the permanent crown is installed.
The provided text describes a 510(k) premarket notification for the Contour Healer Temporary Abutment. It explicitly states that formal clinical studies were not conducted on the device. Instead, the submission relies on bench testing, material conformity, and design validation studies by dental professionals to demonstrate substantial equivalence to a legally marketed predicate device (Zimmer Dental Plastic Temporary Abutment [K092377]).
Therefore, direct acceptance criteria for a study proving device performance in a clinical setting, as well as several of the requested study-specific details, are not applicable or cannot be extracted from this document, as no formal clinical study was performed.
Here's a breakdown of the available information based on the input:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no formal clinical studies were conducted, there are no reported clinical performance metrics in terms of efficacy or safety from a comparative study with specific acceptance criteria. The device's performance is primarily assessed against design specifications, material properties, and a comparison to the predicate device for substantial equivalence.
| Parameter | Acceptance Criteria and Basis | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Dimensional Specifications | Devices must meet all dimensional specifications. (Established through design and manufacturing processes). | First article inspections are done on each molding run to ensure devices meet all dimensional specifications. Routine inspections (100% of devices) ensure each temporary abutment meets design specifications. |
| Fit (Passive) | Correct passive fit of the temporary abutment into the corresponding implant analog. (Ensures compatibility and proper seating with implant systems). | Routine inspections include a check for correct fit (passive) of the temporary abutment into the corresponding implant analog. |
| Screw Fit | Correct screw fit into the temporary abutment. (Ensures secure attachment). | Routine inspections include a check for correct screw fit into the temporary abutment. |
| Visual Inspection | Absence of flash and debris. (Ensures product quality and safety). | Routine inspections include visual inspection of each piece for flash and debris. |
| Material Biocompatibility | Biocompatibility demonstrated per ISO 10993 standards for cytotoxicity, irritation, delayed contact hypersensitivity, and acute systemic toxicity. (Ensures material safety for biological contact). | Biocompatibility of the finished, sterilized temporary abutments was demonstrated per ISO 10993, covering cytotoxicity, irritation, delayed contact hypersensitivity, and acute systemic toxicity. |
| Stainless Steel Screw | Meets specified chemical analysis and 11 different performance specifications per standards. (Ensures strength and material integrity of the screw). | The stainless steel screws are purchased to specification and received with certification testing results for chemical analysis and 11 different performance specifications per standards. |
| Safety and Efficacy (User Validation) | No unexpected or device-related adverse events or complications. Product labeling is clear and appropriate for the intended use and indications. (User confirmation of practical safety and intended function). | Formal design validation studies performed by several dental professionals confirmed the safety and efficacy of the device design for the intended use and ensured clear and appropriate product labeling. No unexpected or device-related adverse events or complications were found in these studies. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: For the "design validation studies done by several dental professionals," the specific sample size (number of professionals or number of cases evaluated) is not provided.
- Data Provenance: The document does not specify the country of origin. The studies appear to be prospective design validation studies as a part of the device development and submission process, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: "Several dental professionals" were used for formal design validation studies. A specific number is not provided.
- Qualifications of Experts: The specific qualifications (e.g., years of experience, specialization) of these dental professionals are not provided. However, their professional role (dental professionals) suggests they are qualified to assess dental devices.
4. Adjudication Method for the Test Set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the design validation studies. The statement "no unexpected or device-related adverse events or complications were found" suggests qualitative feedback rather than a quantitative adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Formal clinical studies were not conducted on the device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental abutment, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used:
- For the design validation studies, the "ground truth" was essentially expert assessment/consensus of dental professionals regarding the device's safety, efficacy, and appropriate labeling in a practical, real-world context (though not a formal clinical trial).
- For the manufacturing and material testing, the "ground truth" was established by predetermined engineering specifications, dimensional tolerances, and ISO standards (e.g., ISO 10993).
8. The Sample Size for the Training Set:
- Not applicable. As this is a physical medical device and not an AI algorithm, there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8).
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K//2099
FEB - 3 2012
510(k) Summary
This summary of information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
Submitter Information
510(k) owner's name:Contour Healer, LLC. Address:1117 Ditchley Road, Virginia Beach, VA 23451 USA Phone number: 757 288 6671 Fax number:757-428-3470 Name of contact person:Allen Hardin White, III, D.D.S. Date of Summary:September 2011
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Device Trade Name: Contour Healer Temporary Abutment
Device Classification Name: Endosseous Dental Abutment
Classification: Class II, 21 CFR 872.3630; Product Code NHA
Legally marketed device to which equivalence is claimed:Zimmer Dental Plastic Temporary Abutment [K092377]
Device Description
The Contour Healer. LLC product line includes pre-manufactured dental abutments intended to serve as a temporary dental prosthesis during the healing process until a permanent crown is fabricated. The abutment is made of PEEK Classix and is directly connected to the endosseous dental abutment by a stainless steel screw.
These abutments have biconvex domes to mimic emergence of the original tooth morphology. and therefore provide for a more esthetic gingival contour during the restorative phase. The abutments come in several abutment- to-implant diameters. The abutments are intended for single-use not to exceedninety days. At the end of the treatment period, the temporary abutment is to be removed by clinician and the permanent crown is installed.
Indications for Use
The Contour Healer Temporary Abutment is intended for use with a root-form endosseous dental abutment to aid in prosthetic rehabilitation. The abutment is a provisional restoration that aids in creating an esthetic emergence through the healing period. The device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed.
These abutments are designed to work with the following implant systems:
Zimmer [Screw-Vent Dental Implant System]
Nobel Biocare (Replace HA Coated Implant, Replace TiUnite Endosseous Implant, Nobel Biocare Endosseous Implants, and Groovy Implants]
BioHorizons [BioHorizons Tapered Internal Implant System].
Testing
First article inspections are done on each molding run to ensure that the devices meet all dimensional specifications. Routine inspections are done on 100% of the Contour Healer devices to ensure that each temporary abutment meets design specifications. This finishing and inspection process includes hand polishing of each piece, visual inspection of each piece for flash and debris, a check for correct fit [passive] of temporary abutment into the corresponding implant analog fto ensure that each piece will fit into the corresponding implant], and a check for correct screw fit into the temporary abutment, before final packaging of each piece.
The stainless screw used with each model of the temporary dental abutment are purchased to specification from the manufacturer and are received by Contour Healer with certification testing results for chemical analysis and 11 different performance specifications per standards.
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Biocompatibility of the finished, sterilized temporary abutments was demonstrated per ISO-Dioompanishility of the liner of otoxicity, irritation, delayed contact hypersensitivity, and acute systemic toxicity.
Formal clinical studies were not conducted on the device since [per the FDA Guidance r orniture from Endosseous Dental Implants and Endosseous Dental Implant Abutments" issued on May 12, 2004]: 1] the material formulation is identical to a device Anouthously cleared for this intended use, 2] the design is similar to the design of the predicate proviously diourou for the Contour Healer temporary dental abutment models are devices, of the imgth's or caphant diameters for each of the models are all greater than 3.25 greater than 7 mm, 17 the accompanying or recommended implant abutment is less than min, of the ungalation of the abogy required for the manufacture or the deployment of the 50 , of the now tow township, require identical to those of the previously cleared devices of the same type.
However, formal design validation studies have been done on the Contour Healer devices by roweral dental professionals to confirm the safety and efficacy of the device design for the intended use, and to ensure that the product labeling is clear and appropriate for theindications intended use, and to onears that the propected or device-related adverse events or complications were found in these studies.
| Parameter | Device | Predicate Device |
|---|---|---|
| Device Name | Contour Healer | Plastic Temporary Abutment |
| Company Name | Contour Healer, LLC | Zimmer Dental, Inc. |
| 510(k) # | TBD | K092377. |
| Class | II | Same |
| 21 CFR number | 872.3630 | Same |
| 21 CFR category | Endosseous dental abutment [temporary] | Same |
| Code | NHA | Same |
| Parameter | Device | Predicate Device |
| Description | Abutment is a plastic post with a predefined junction and abutment core. The plastic stem of the abutment engages the internal aspects of the endosseous implant and is secured with a separate retaining screw. The abutment is packaged with a stainless steel screw for retaining the temporary healing abutment to the endosseous implant. The abutments are provided in straight versions only. | Abutment is a plastic post with a predefined margin and abutment cone; available in multiple cuff heights and straight and angled cone variations. The plastic hex of the abutment engages the internal hex of the Tapered Screw-Vent or Screw-Vent Implant and is secured with a separate retaining screw.Abutment is packaged with two screws, a long processing screw for fabricating a screw-retained temporary restoration and a short retaining screw for fabricating a cement-retained restoration |
| Use Features | Pre-manufactured prosthetic component; screw-retained | Same; cement-retained or screw-retained |
| Ancillary components | Not applicable; for attachment to endosseous permanent implant | Same |
| Intended Use | To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation | Same |
| Indications for use | A provisional restoration that aids in creating an esthetic emergence through the gingiva during the healing periodThe device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed. | To fabricate and support provisional restorations that aid in creating and esthetic emergence through the gingiva during the healing period, before final restorationSingle- or multi-unit restorations |
| End User | Dentist, periodontist, oral surgeon | Same |
| Frequency of Use | Single use | Same |
| Method of Use | Temporary prosthesis; 90 days maximum | Same; 180 days maximum |
| Parameter | Device | Predicate Device |
| Contraindications | Not to be used as a final abutment; not to beused "in occlusion"; not to be used as a"cast-to" abutment | Same |
| Standards met | ISO 10993; ISO 14971 | ISO 10993 |
| AbutmentMaterial | PEEK Classix; polyetheretherketone | Same |
| Screw material | Stainless steel | Titanium alloy |
| Design [style,size] | Contoured shaped with interfaces to matchendosseous implants with various platformsize [abutment to implant diameters of 5.0,4.3, 4.5, and 5.7mm], in straight versionsonly | Straight and angled versions,with interfaces to match threediameters of tapered screw-vent implants [3.5, 4.5, and 5.7mm], 1 mm and 4 mm cuffheight options |
| Screw geometry | Internal hex with friction fit | Internal hex [anti-rotational]with friction fit |
| Sterility | Non-sterile; intended for autoclavesterilization by end user | Sterilized by gamma irradiation,but instructions for autoclavingby the end user are provided |
| Packaging | Round plastic vial with screw cap | Sealed Tyvek blister packs |
Summary Comparison Table of New Device to Predicate Device
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Device Comparison Statement
The new device and the predicate devices are temporary dental abutments consisting of a plastic post with a predefined junction and abutment core. In both devices the plastic stem of the abutment engages the internal aspects of the endosseous implant and is secured with a separate stainless steel retaining screw.
The Contour Healer differs from the predicate device in that the shape more closely mimics the shape of the permanent crown as opposed to a straight cylinder. The most difficult stage of implant surgery is to manage the peri-implant soft tissue contour. Shape and form of the periimplant tissues are equally as important as other important factors such as bone quantity/ quality, primary stability, and bone to implant contact. The Contour Healer abutment serves as a template to easily shape the soft tissue to proper form and allows the natural contours to be maintained without compromising the stability of the newly placed implant. The restorative phase is easier as the tissues are ready to be impressed along with the impression coping on the implant.
The Contour Healerproduct for the management of the peri-implant soft tissue contour issubstantially equivalent to the previously-cleared device, with the same indications for use, abutment material, and similar design and technological characteristics and therefore does not raise any new questions for safety. Contour Healer has further supported the safety and the efficacy of this product by user design validation.
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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is in all caps. There is also a logo on the left side of the text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Allen Hardin White, III, D.D.S. CEO Contour Healer, LLC 1117 Ditchley Road Virginia Beach, Virginia 23451
FEB - 3 2012
Re: K112099
Trade/Device Name: Contour Healer Temporary Dental Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 9, 2012 Received: January 19, 2012
Dear Dr. White:
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. 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.
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Page 2 - Dr. White
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours ..
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K112099
Device Name: Contour Healer Temporary Dental Abutment
Indications for Use:
The Contour Healer Temporary Abutment is intended for use with a root-form endosseous dental abutment to aid in prosthetic rehabilitation. The abutment is a provisional restoration that aids in creating an esthetic emergence through the gingiva during the healing period. The device is for use by dental professionals for single restorations in adults. The device is for single-use only and may not be re-processed.
These abutments are designed to work with the following implant systems:
Zimmer [Screw-Vent Dental Implant System]
Nobel Biocare [Replace HA Coated Implant, Replace TiUnite Endosseous Impiant, Nobel Biocare Endosseous Implants, and Groovy Implants]
BioHorizons [BioHorizons·Tapered Internal Implant System].
Susan Rose
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112099
Prescription Use _ × (Part 21 CFR 801 Subpart D)
§ 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.)