(104 days)
Not Found
No
The description focuses on the physical properties and mechanical function of ceramic orthodontic brackets, with no mention of AI or ML.
Yes
The device is described as being "intended for the correction of orthodontic malocclusions," indicating its purpose is to treat a medical condition.
No
Explanation: The device is described as an orthodontic bracket intended for correcting malocclusions, not for diagnosing them. The text specifically states that the malocclusions are "as diagnosed by a dentist or orthodontist," implying the diagnosis occurs prior to and separate from the device's use.
No
The device description clearly states it is a physical ceramic bracket made of polycrystalline aluminum oxide, intended to be bonded to teeth and interface with an archwire. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these ceramic brackets are used to physically move teeth for the correction of orthodontic malocclusions. They are bonded directly to the teeth and interact with an archwire to apply force.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The device's function is purely mechanical and applied externally to the teeth.
The device is a medical device used for treatment, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
These devices are intended for the correction of orthodontic malocclusions as diagnosed by a dentist or orthodontist. They are used to transmit and provide axial directional control to the kinetic energy from an orthodontic archwire, for movement of individual teeth for treatment.
These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have interface with the archwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
The Ceramic Bracket line of products are single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.
These one-piece ceramic brackets are comprised of polycrystalline aluminum oxide. The general geometric composition of these devices is made of archwire slot, tie wings, and a pad (which provides a bonding surface). The archwire slot is a channel through the bracket used to engage the archwire. The tie wings are small hook shaped protrusion use as an anchor point for the ligatures work by tying the archwire into the archwire slot. The geometry of the pad is such that the bracket has a stable footprint. The pad is coated with aluminum oxide particles to facilitate bracket bonding with orthodontic adhesives.
These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the teeth they are intended for. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
individual teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist or orthodontist / Not Found
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)
Descriptive and performance testing demonstrate substantial equivalence.
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.
Not Found
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
§ 872.5470 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
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:
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MAY 1 9 2011
5.510(k) Summary
- :
: .
14
1
510k Summary
Device Name:
.
Ceramic Brackets
Submitter's Name, address, telephone number, contact person, and date the summary was prepared:
| Submitter's Name: | Ortho Organizers Inc. |
|---|---|
| Submitter's Address: | 1822 Aston Ave. Carlsbad, CA 92008 |
| Submitter's Telephone: | 760-448-8600 |
| 760-448-8613 fax | |
| Submitter's Contact: | |
| Assurance | Foster Boop, Director of Regulatory Affairs and Quality |
| Email: | Foster.Boop@OrthoOrganizers.com |
| Ph. 760-448-8600 ext 146 |
Date 510(K) Summary Prepared: January 31, 2011
Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:
| Proprietary Name: | Undetermined |
|---|---|
| Common or Usual Name: | Ceramic Brackets |
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Classification Code: | NJM |
Identification of Legally Marketed Device: (Device Equivalence)
| Proprietary Name: | Transcend Ceramic Brackets |
|---|---|
| 510K Number: | K861965 |
| Common or Usual Name: | Ceramic Brackets |
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Classification Code: | DYW |
| Device Manufacturer: | 3M-Unitek Corp. |
2
| Proprietary Name: | Transcend Ceramic Brackets |
|---|---|
| 510K Number: | K944286 |
| Common or Usual Name: | Ceramic Brackets |
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Classification Code: | DYW |
| Device Manufacturer: | 3M-Unitek |
| Proprietary Name: | Clarity Modified Ceramic Bracket |
| 510K Number: | K062305 |
| Common or Usual Name: | Ceramic Brackets |
| Classification Name: | Bracket, Ceramic, Orthodontic |
| Classification Code: | NJM |
| Device Manufacturer: | 3M-Unitek |
Description of the Device:
The Ceramic Bracket line of products are single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth.
These one-piece ceramic brackets are comprised of polycrystalline aluminum oxide. The general geometric composition of these devices is made of archwire slot, tie wings, and a pad (which provides a bonding surface). The archwire slot is a channel through the bracket used to engage the archwire. The tie wings are small hook shaped protrusion use as an anchor point for the ligatures work by tying the archwire into the archwire slot. The geometry of the pad is such that the bracket has a stable footprint. The pad is coated with aluminum oxide particles to facilitate bracket bonding with orthodontic adhesives.
These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the teeth they are intended for. These geometries contribute to the fit of the bracket to the tooth and also impart the axial control of the energy from the archwire.
Intended Use:
These devices are intended for the correction of orthodontic malocclusions as diagnosed by a dentist or orthodontist. They are used to transmit and provide axial directional control to the kinetic energy from an orthodontic archwire, for movement of individual teeth for treatment.
3
Summary of the technological characteristics of the device compared to the predicate devices:
The Ortho Organizer Ceramic Bracket System is substantially equivalent to the 3M Unitek Ceramic Bracket System. Table 1 summarizes the technological characteristics of this equivalence:
Table 1.
| Product
Parameter | Bracket | Predicate Product:
3M Unitek Transcend
and Clarity* | Ortho Organizer's
ceramic brackets | Substantial
Equivalence Analysis |
|-----------------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 510k Number | All | K861965, K944286,
K062305 | Pending | N/A |
| Intended use
per 872.5470 | All | intended to be
bonded to a tooth to
apply pressure to a
tooth from a flexible
orthodontic wire to
alter the tooth's
position | intended to be
bonded to a tooth to
apply pressure to a
tooth from a flexible
orthodontic wire to
alter the tooth's
position | Equivalent |
| Bracket Body
Material | All | 99.9% Polycrystalline:
aluminum oxide | 99.9% Polycrystalline
aluminum oxide | Equivalent |
| Pad Coating
Material | All | Irregular
Microcyrstalline
Aluminum Oxide | Irregular
Microcyrstalline
Aluminum Oxide | Equivalent |
| Biocompatibility | All | Yes | Yes | Equivalent |
| Single Use | All | Yes | Yes | Equivalent |
| Non-Sterile
packaging | All | Yes | Yes | Equivalent |
| Color coded
indicator for
bracket
identification | All | Yes | Yes, optional | Equivalent |
- A claim of Substantial Equivalence to the 3M Unitek Ceramic Bracket system is not made for the metal insert feature available in this product line. The Transcend Bracket, like the Ortho Organizer Ceramic Bracket, does not include this feature.
Conclusion:
The Ortho Organizer Ceramic Bracket System has the same intended use and similar technological characteristics as the predicate device. The minor differences in technological characteristics do not raise new types of safety and effectiveness questions. Descriptive and performance testing demonstrate substantial equivalence.
17
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo.
MAY 1 9 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Foster Boop Director of Regulatory Affairs and Quality Ortho Organizers, Incorporated 1822 Aston Avenue Carlsbad, California 92008-7603
Re: K110335
Trade/Device Name: Ceramic Brackets Impression Compound Regulation Number: 21 CFR 872.5470 Regulation Name: Plastic Orthodontic Bracket Regulatory Class: II Product Code: NJM Dated: January 31, 2011 Received: February 15, 2011
Dear Mr. Boop:
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.
5
· Page 2 - Mr. Boop
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/ ucm 1 1 5809.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
6
Indications for Use
510(k) Number (if known):
Device Name: Ceramic Brackets
Indications for Use:
These ceramic brackets will be used for correction of malocclusions as diagnosed and overseen by trained practitioners of orthodontics. These brackets will be directly bonded to teeth; will have interface with the archwire to direct applied forces. These devices are intended for single use only and are not delivered in a sterile state.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE).
Susan Rummer
(Division Sign-Off) Division of Anesthesiology, General Hospital .nfection Control, Dental Devices
510(k) Number: K110335