(37 days)
Not Found
No
The device description and intended use describe a passive orthodontic bracket, and there is no mention of AI, ML, or any related technologies in the provided text.
Yes
The device is used for "orthodontic movement of teeth," which is a therapeutic intervention aimed at correcting dental alignment.
No
The "Intended Use" states that the device is "indicated for orthodontic movement of teeth," which is a treatment function, not a diagnostic one. The "Device Description" also details how the brackets are used to "produce desired tooth movement." There is no mention of the device being used to identify or analyze a disease or condition.
No
The device description clearly states that the device is a physical ceramic bracket made of aluminum oxide, which is bonded to teeth and linked by 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 Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are physical devices bonded to teeth to facilitate orthodontic movement. They do not perform any tests on bodily samples.
- Intended Use: The intended use is "for orthodontic movement of teeth," which is a mechanical process, not a diagnostic one.
The information provided clearly describes a physical orthodontic appliance, not a diagnostic test.
N/A
Intended Use / Indications for Use
The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are indicated for orthodontic movement of teeth.
Product codes (comma separated list FDA assigned to the subject device)
NJM
Device Description
LAR Manufacturing, LLC Ceramic Brackets are available if the following prescriptions: Exceed Series Brackets Roth .018" & .022" Slot Sizes Accent Series Roth .018" & .022" Slot Sizes; Edgewise .018" & .022" Slot Sizes; Ricketts .018" Slot Size; Bio-Progressive/Hilgers .018" & .022" Slot Sizes The Exceed Series and Accent Series Ceramic Brackets are produced using Al2O3, translucent polycrystalline aluminum oxide (99.9%). These Ceramic Brackets are bonded to the teeth with commercially available materials and linked together by "archwire" that applies steady, gentle pressure to produce desired tooth movement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Not Found
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
.
| LAR Manufacturing, LLC | |
|---|---|
| Orthodontic Ceramic Brackets | SEP 23 2005 |
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is
being submitted in accordance with the requirements of 21 C.F.R.
$ 807.92. | | | | |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Submission
Correspondant:
Phone:
Fax:
Contact:
e-mail: | Emergo Group Inc.
2454 McMullen Booth Road, Suite 427
Clearwater, FL 33759 USA
727-797-4727
727-797-4757
lan Gordon
Senior Vice President
igordon@emergogroup.com | | | | |
| Submission
Sponsor: | LAR Manufacturing, LLC
6828 Commerce Ave.
Port Ritchey, FL 34668 | | | | |
| Date Prepared | August 5, 2005 | | | | |
| Name of device | Orthodontic Ceramic Brackets - Accent Series and Exceed
Series Ceramic Brackets | | | | |
| Classification
Names | Bracket, Ceramic, Orthodontic | | | | |
| Device
Classification | Regulatory Class: II
Product Code: NJM
Classification Panel: Dental
Regulation Number: 21 C.F.R. 872.5470 | | | | |
1
510(k) Summary of Safety and Effectiveness
LAR Manufacturing, LLC Orthodontic Ceramic Brackets
.
| Predicate
| Device(s) | ||
|---|---|---|
| 510(k)# | Device | Manufacturer |
| K042178 | Mystic Orthodontic | |
| Ceramic Brackets | Dentsply International | |
| Device | ||
| Description | LAR Manufacturing, LLC Ceramic Brackets are available if | |
| the following prescriptions: | ||
| Exceed Series Brackets Roth .018" & .022" Slot Sizes Accent Series Roth .018" & .022" Slot Sizes; Edgewise .018" & .022" Slot Sizes; Ricketts .018" Slot Size; Bio-Progressive/Hilgers .018" & .022" Slot Sizes The Exceed Series and Accent Series Ceramic Brackets are | ||
| produced using Al2O3, translucent polycrystalline aluminum | ||
| oxide (99.9%). These Ceramic Brackets are bonded to the | ||
| teeth with commercially available materials and linked together by "archwire" that applies steady, gentle pressure to produce desired tooth movement. | ||
| Indications | LAR Manufacturing, LLC Orthodontic Ceramic Brackets are | |
| indicated for orthodontic movement of teeth. | ||
| Technological | ||
| Characteristics | The function and performance of the LAR Manufacturing, | |
| LLC Orthodontic Ceramic Brackets are identical to the | ||
| predicate device listed above. There is no difference in | ||
| fundamental scientific technology. The LAR Manufacturing, | ||
| LLC Orthodontic Ceramic Brackets are made of the same | ||
| material as the predicate device currently on the market and | ||
| has the same overall intended use. | ||
| Conclusion | By definition, a device is substantially equivalent when the | |
| device has the same intended use and the same | ||
| technological characteristics as the predicate device. | ||
| There are no major differences between the LAR | ||
| Manufacturing, LLC and the predicate device cited, and | ||
| therefore the LAR Manufacturing, LLC Orthodontic Ceramic | ||
| Brackets do not raise any questions regarding safety and | ||
| effectiveness. | ||
| The LAR Manufacturing, LLC Orthodontic Ceramic Brackets | ||
| as designed, are as safe and effective as the predicate | ||
| device, and the device is determined to be substantially | ||
| equivalent to the referenced predicate device currently on | ||
| the market. |
2
510(k) Summary of Safety and Effectiveness
LAR Manufacturing, LLC Orthodontic Ceramic Brackets
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three horizontal lines that curve and converge, resembling a stylized human figure.
Public Health Service
SEP 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LAR Manufacturing, LLC C/O Mr. Ian P. Gordon Senior Vice President Emergo Group, Inc. 2454 McMullen Booth Road, Suite 427 Clearwater, Florida 33759
Re: K052245
Trade/Device Name: Accent Series™ Ceramic Brackets and Exceed Series™ Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: August 12, 2005 Received: August 17, 2005
Dear Mr. Gordon:
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.
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. Ian P. Gordon
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that 1 Dry o loualies of our device complies with other requirements of the Act or that FDA has made a decemination and Jaistered by other Federal agencies. You must comply with all reteral statures and regulations animals in the registration and listing (21 CFR Part 807); all the Act s requirements; morading; butacturing practice requirements as set forth in the quality labeling (21 CFR Part 807), E00 mixt 820); and if applicable, the electronic product radiation Systems (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) This letter witi anow you to oegin manetal equivalence of your device of your device to a legally premarked notheation: "The PDF Intently of our 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 If you desire specific darroliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your responsibilities at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K052245
Orthodontic Ceramic Brackets Device Name:
Indications for Use:
The LAR Manufacturing, LLC Orthodontic Ceramic Brackets are indicated for orthodontic movement of teeth.
Prescription Use
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Kein Muley
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D 510(k) Number:
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