(280 days)
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Not Found
No
The description focuses on the material composition and mechanical function of a dental retainer, with no mention of AI or ML capabilities.
Yes
The device is described as an interlock retainer intended to stabilize the lower dental arch following orthodontic treatment, which aligns with the definition of a therapeutic device designed to treat or prevent a medical condition (in this case, teeth shifting after orthodontics).
No
The device, LingLock, is an interlock retainer designed to stabilize the lower dental arch after orthodontic treatment. Its function is to prevent teeth from shifting, not to detect, diagnose, or monitor a medical condition or disease.
No
The device description clearly states that the device is composed of physical components (polycrystalline alumina, polypropylene, stainless steel) that are bonded to the teeth. It is a physical retainer system, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- LingLock's Function: LingLock is a physical device bonded to teeth to stabilize their position after orthodontic treatment. It does not analyze any biological specimens or provide diagnostic information about a patient's health.
The description clearly states its purpose is mechanical stabilization of teeth, not diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of LingLock is to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.
LingLock is an interlock retainer composed of polycrystalline alumina that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.
Product codes
DYW
Device Description
The device is an interlock retainer composed of polycrystalline alumina (aluminum oxide) that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. LingLock is comprised of a set of ceramic attachments (male/female) bonded to the teeth across the contact points of the lower six anterior front teeth; the male component on one side and the female component on the other. When engaged, the ceramic attachments prevent the teeth from shifting out of position, yet have a slight gap which enables patients to floss their teeth interdentally in a regular manner.
The LingLock retainer has an application tool consisting of a ceramic attachment holder (polypropylene) and a guide strip (stainless steel) which ensures an exact positioning of the ceramic attachments both in relation to each other and the teeth to be retained. An orthodontic adhesive is placed on the bonding surface of the ceramic attachments and the guide strip is guided in between two neighbouring teeth. The ceramic attachment holder is brought in contact with the enamel at the lingual surface of the teeth and the orthodontic adhesive is light cured. After curing, the guide strip is removed by pulling it forward in a slight upward rotational movement. The ceramic attachment holder is then removed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
lower anterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Ormco Corporation, Bondable Lingual Retainer; 3M Unitek, Clarity Ceramic Brackets
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a simple, sans-serif font. The logo is black and white.
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
JAN 1 9 2007
Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 (949) 255-8766 - Phone (949) 255-8763 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: April 2006
Device Name:
- Trade Name LingLock .
- Common Name Lingual Orthodontic Retainer .
- Classification Name Retainer, Screw Expansion, Orthodontic, per 21 CFR § 872.5410 .
Devices for Which Substantial Equivalence is Claimed:
- . Ormco Corporation, Bondable Lingual Retainer
- 3M Unitek, Clarity Ceramic Brackets .
Device Description:
The device is an interlock retainer composed of polycrystalline alumina (aluminum oxide) that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. LingLock is comprised of a set of ceramic attachments (male/female) bonded to the teeth across the contact points of the lower six anterior front teeth; the male component on one side and the female component on the other. When engaged, the ceramic attachments prevent the teeth from shifting out of position, yet have a slight gap which enables patients to floss their teeth interdentally in a regular manner.
The LingLock retainer has an application tool consisting of a ceramic attachment holder (polypropylene) and a guide strip (stainless steel) which ensures an exact positioning of the ceramic attachments both in relation to each other and the teeth to be retained. An orthodontic adhesive is placed on the bonding surface of the ceramic attachments and the guide strip is guided in between two neighbouring teeth. The ceramic attachment holder is brought in contact with the enamel at the lingual surface of the teeth and the orthodontic adhesive is light cured. After curing, the guide strip is removed by pulling it forward in a slight upward rotational movement. The ceramic attachment holder is then removed.
1
Intended Use of the Device:
The intended use of LingLock is to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.
Substantial Equivalence:
LingLock is substantially equivalent to other legally marketed devices in the United States. Linglock functions in a manner similar to and is intended for the same use as the Bondable Lingual Retainer currently manufactured by Ormco Corporation and is composed of the same material and has the same bonding surface as the ceramic bracket manufactured by 3M Unitek.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Colleen Boswell Vice President, Regulatory Affairs Sybron Dental Specialist, Incorporated 100 Bayview Circle, Suite 6000 Newport Branch, California 92660-8915
JAN 1 9 2007
Rc: K061042
Trade/Device Name: LingLock Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: December 29, 2006 Received: January 4, 2007
Dear Ms. Boswell:
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.
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Page 2 - Ms. Boswell
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suen Kumno
Chiu Lin, Ph.D. 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
Koblo 42 510(k) Number (if known):
Device Name: LingLock
Indications For Use:
LingLock is an interlock retainer composed of polycrystalline alumina that is bonded to the lingual surface of the lower anterior teeth and is intended to stabilize the lower dental arch following orthodontic treatment. The LingLock retainer enables patients to floss their teeth interdentally in a regular manner.
Suer Uunm
1 CE SB XOL 4 Coquor, Dental De
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)