(155 days)
Not Found
No
The summary describes a physical device (aligners) and its intended use for tooth repositioning. There is no mention of AI, ML, image processing, or any data-driven algorithms in the device description or performance studies sections.
Yes
The device is indicated for the treatment of tooth malocclusion, which is a medical condition, and it repositions teeth through continuous gentle force.
No
The device, ClearCorrect System, is indicated for the "treatment of tooth malocclusion" and "progressively reposition the teeth," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states the device is fabricated of "clear, thin, thermoformed polycarbonate plastic," indicating it is a physical, hardware-based device (aligners).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- ClearCorrect System's Function: The ClearCorrect System is a device used directly on the patient's teeth to physically reposition them. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states "treatment of tooth malocclusion," which is a therapeutic purpose, not a diagnostic one based on analyzing samples.
- Device Description: The description details the physical nature of the aligners and how they apply force to the teeth. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the ClearCorrect System is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The ClearCorrect device is fabricated of clear, thin, thermoformed polycarbonate plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
A dental health care professional (e.g. orthodontist or dentist)
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Invisalian/Align System. Align Technology Inc., K981095, Clear Image Aligners, Specialty Appliances Works, Inc., K071970
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
0
Submitter: ClearCorrect
ClearCorrect Premarket Notification: Traditional 510(k)
510(k) Summary
FEB - 6 2009
Submitter Name: ClearCorrect, Inc. 5200 Mitchelldale St., Ste F-26 Submitter Houston, TX 77092 Address: 713-850-1036 Phone Number: 713-248-9415 Fax Number: Contact Person: Jarrett Pumphrey 30 August 2008 Date Prepared: ClearCorrect Device Trade Name: Common Name Clear Braces Classification Sequential Aligner 852.5470 Name, Number & Product Code: NXC Invisalian/Align System. Align Technology Inc., K981095 Predicate Devices: Clear Image Aligners, Specialty Appliances Works, Inc., K071970 Device Description: The ClearCorrect device is fabricated of Device Description clear, thin, thermoformed polycarbonate plastic in a and Statement of sequential series to progressively reposition the teeth. Intended Use Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner. Intended Use: The CearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force. A dental health care professional (e.g. orthodontist or Summary of dentist), prescribes the ClearCorrect system based on an Technological assessment of the patient's teeth, determines a course of Characteristics treatment with the system, takes molds of the patient's teeth,
1
and completes a prescription form The molds and prescription are sent to ClearCorrect. Utilizing standard, dental software used for tooth alignment. ClearCorrect designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, ClearCorrect produces the trays, which are formed of clear, thin, thermoformed polycarbonate plastic. The trays are sent back to the dentist, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the physician to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at anv time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced above.
Conclusion
The information discussed above demonstrates that the ClearCorrect device is substantially equivalent to the predicate devices
Declarations
- o This summary includes only information that is also covered in the body of the 510(k).
- o This summary does not contain any puffery or unsubstantiated labeling claims.
- · This summary does not contain any raw data, i.e., contains only summary data.
- o This summary does not contain any trade secret or confidential commercial information.
- o This summary does not contain any patient identification information.
2
Summary of Technical Characteristics
| Feature | ClearCorrect | Invisalign/Align System | Clear Image Aligners |
|---|---|---|---|
| 510(k) Number | Not yet assigned | K981095 | K071970 |
| Manufacturer | ClearCorrect, Inc. | Align Technology Inc | Specialty Appliances |
| Works, Inc | |||
| Classification # & | |||
| Product Code | 852.5470 | ||
| NXC | 852.5470 | ||
| NXC | 852.5470 | ||
| NXC | |||
| Intended Use | The ClearCorrect | ||
| System is indicated for | |||
| the treatment of tooth | |||
| malocclusion in | |||
| patients with | |||
| permanent dentition | |||
| (i.e. all second molars). | |||
| The ClearCorrect | |||
| System positions teeth | |||
| by way of continuous | |||
| gentle force. | The Align System is | ||
| indicated for the | |||
| treatment of tooth | |||
| malocclusion in | |||
| patients with | |||
| permanent dentition | |||
| (i.e., all second | |||
| molars). The Align | |||
| System positions teeth | |||
| by way of continuous | |||
| gentle force. | The Clear ImageTM | ||
| Aligners system is | |||
| intended to correct | |||
| minor discrepancies in | |||
| the alignment of | |||
| maloccluded anterior | |||
| teeth on patients with | |||
| permanent dentition | |||
| (second molars) by | |||
| moving the teeth with a | |||
| progressive series of | |||
| clear thin, | |||
| thermoformed plastic | |||
| aligners, fabricated in | |||
| stages to gradually | |||
| align the teeth over a | |||
| period of several | |||
| months. The aligners | |||
| are completely | |||
| removable by the | |||
| patient and may be | |||
| discontinued at any | |||
| time. | |||
| Mode of Action | Alignment of teeth by | ||
| sequential use of | |||
| preformed plastic | |||
| trays. | Alignment of teeth by | ||
| sequential use of | |||
| preformed plastic | |||
| trays. | Alignment of teeth by | ||
| sequential use of | |||
| preformed plastic trays. | |||
| Material | Thermoformed | ||
| polycarbonate | Thermoformed | ||
| polycarbonate | Thermoformed | ||
| polycarbonate | |||
| OTC or Rx | Rx | Rx | Rx |
・
,
.
.
.
·
.
. .
.
,
.
....
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three legs, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ClearCorrect, Incorporated c/o Mr. William Greenrose President Oserve America, Incorporated 220 River Road Claremont, New Hampshire 03743
Re: K082556
Trade/Device Name: ClearCorrect Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: January 15, 2009 Received: January 16, 2009
Dear Mr. Greenrose:
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.
FEB - 6 2009
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. Greenrose
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Soutte Y. Michie Davis.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4.1 Indications for Use Statement
510(k) Number (if known): K082556
Device Name: ClearCorrect
Indications for Use:
The CearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K082556 |
|---|---|
| ---------------- | --------- |
Section 4.0
CONFIDENTIAL