(172 days)
No
The description focuses on CAD/CAM fabrication of a dental prosthetic and material testing, with no mention of AI or ML.
No
A therapeutic device is one that treats, mitigates, or cures a disease. This device is a dental prosthetic component for restoration, not a therapeutic treatment.
No
The device is a dental prosthetic component (crown) used for restoration, not for diagnosing medical conditions.
No
The device description explicitly states the ATLANTIS™ Crown is a physical component made of yttria stabilized zirconia powder and fabricated using CAD/CAM technology, indicating it is a hardware device, not software-only.
Based on the provided information, the ATLANTIS™ Crown is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ATLANTIS™ Crown Function: The ATLANTIS™ Crown is a dental prosthetic component. Its purpose is to function as a substructure and final restoration in a patient's mouth, supporting a single-tooth prosthetic. It is a physical device implanted or placed in the body, not used to analyze biological samples.
- Intended Use: The intended use clearly describes its function as a dental restoration component, not for diagnostic testing.
- Device Description: The description focuses on the material (zirconia), fabrication method (CAD/CAM), and its role in supporting a dental restoration.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic information, or any of the typical characteristics associated with IVD devices.
Therefore, the ATLANTIS™ Crown falls under the category of a dental prosthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ATLANTISTM Crown is intended for use with an ATLANTISTM Abutment and an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient.
Product codes
EIH
Device Description
The ATLANTIS™ Crown is a patient-specific dental prosthetic component intended for use with an ATLANTISTM Abutment, abutment screw, and an endosseous implant to support a single-tooth prosthetic restoration. The ATLANTIS™ Crown is made of yttria stabilized zirconia powder (Y-TZP) and fabricated according to the clinician's prescription using CAD/CAM technology. The crown can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer. The ATLANTIS™ Crown is finally cemented to the ATLANTIS™ Abutment.
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
Flexural strength testing were conducted on the Zirconia material used for the ATLANTIS™ Crown according to the standards ISO 14704 and ASTM C1161. The results showed that the requirements of the standard ISO 6872 Dentistry Ceramic Materials were fulfilled. Fracture toughness, chemical solubility, radioactivity concentration and coefficient of thermal expansion were tested and completed according to the requirements specified in ISO 6872. The material used for the ATLANTIS™ Crown and the manufacturing process is the same as used for the predicate device ATLANTIS™ Crown Abutment in Zirconia, K 110356. Therefore no additional biocompatibility testing has been performed.
Key Metrics
Not Found
Predicate Device(s)
Cercon ht, K112152
Reference Device(s)
ATLANTIS Crown Abutment in Zirconia, K110356
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with the profiles overlapping to create a sense of depth. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2016
DENTSPLY International Inc. Ms. Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17401
Re: K152247
Trade/Device Name: ATLANTISTM Crown Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 16, 2015 Received: December 22, 2015
Dear Ms. Lewis:
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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tina Kiang
-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
K152247 510(k) Number (if known):
Device Name: ATLANTIS™ Crown
Indications for Use:
The ATLANTIS™ Crown is intended for use with an ATLANTIS™ Abutment and an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
for
ATLANTISTM Crown
Image /page/3/Picture/3 description: The image shows the word "Dentsply" in a bold, sans-serif font. The letters are all capitalized and black. The word is slightly angled upwards from left to right. The background is white.
- Submitter Information: DENTSPLY International, Inc. Susquehanna Commerce Center 221 West Philadelphia Street, Ste. 60 York, PA 17401
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: 04 August 2015
2. Device Name:
- . Proprietary Name: ATLANTISTM Crown
- classification Name: Porcelain powder for clinical use .
- CFR Number: .
- Device Class: .
- Product Code: .
3. Predicate Device:
| Primary Predicate: | Cercon ® ht, K112152 (DENTSPLY International Inc.) |
|---|---|
| Reference Predicate: | ATLANTIS TM Crown Abutment in Zirconia, K110356 (DENTSPLY Implants, formerly ASTRA TECH Inc.) |
21 CFR 872.6600
Class II
EIH
The ATLANTIS™ Crown Abutment in Zirconia, (K110356) has been chosen as reference predicate regarding biocompatibility since the material and CAD/CAM milling process is identical to the proposed device.
4. Description of Device:
The ATLANTIS™ Crown is a patient-specific dental prosthetic component intended for use with an ATLANTISTM Abutment, abutment screw, and an endosseous implant to support a single-tooth prosthetic restoration. The ATLANTIS™ Crown is made of yttria stabilized zirconia powder (Y-TZP) and fabricated according to the clinician's prescription using CAD/CAM technology. The crown can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer. The ATLANTIS™ Crown is finally cemented to the ATLANTIS™ Abutment.
5. Indications for Use:
The ATLANTIS™ Crown is intended for use with an ATLANTIS™ Abutment and an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient.
DENTSPLY International
World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com
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| Comparison of the Technological Characteristics: | |||
|---|---|---|---|
| Proposed Device | Primary Predicate Device | Reference Predicate Device | |
| ATLANTISTM Crown | Cercon® ht (K112152) | ATLANTISTM Crown Abutment in Zirconia (K110356) | |
| Indications for use | The ATLANTIST™ Crown is intended for use | ||
| with an ATLANTIST™ Abutment and an | |||
| endosseous implant to function as a | |||
| substructure that also serves as the final | |||
| restoration, in a partially or completely | |||
| edentulous patient. | Cercon® ht is indicated in the anterior and | ||
| posterior segments for: |
- crowns
- telescopic primary crowns
- multi-unit bridges (with no more than two
pontics between abutment crowns)
Cercon® ht can be used as a substructure
(framework) which is then veneered with a
dental veneering ceramic or can be used for
full-contour application (without veneering)
as well. In the case of telescopic primary
crowns the substructure is not
veneered. | The Atlantis Crown Abutment in Zirconia
is intended for use with an endosseous
implant to function as a substructure that
also serves as the final restoration, in a
partially or completely edentulous patient.
The prosthesis is screw retained. The
abutment screw is intended to secure the
crown abutment to the endosseous
implant.
This device is compatible with the
following manufacturers' implant systems:
Astra - Microthread ST 3.5mm, 4.0mm,
4.5mm and 5.0mm.
Please note: This device may be used in an
early load situation, but is dependent on
the specific implant system and protocol
used by the dental professional. Highly
angled abutments on small diameter
implants are intended for the anterior
region of the mouth only. |
| Design | Provided to the customer as patient-specific
full contour crown or cut-back substructure. | Provided as blank to the dental laboratory to
create a patient-specific full contour crown
or substructure | Provided as a patient-specific abutment,
available in the diameters: 3.5 mm, 4.0
mm, 4.5 mm, 5.0 mm |
| Manufacturing
method | 1. pre-sintered blanks
- milling of crown by DENTSPLY
Implants - final sintering by DENSPLY Implants | 1. pre-sintered blanks
- machining of crown by dental
laboratory - final sintering by dental laboratory | 1. pre-sintered blanks
- milling of abutment by DENTSPLY
Implants - final sintering by DENTSPLY
Implants |
| Material | Y-TZP | Y-TZP | Y-TZP |
Substantial Equivalence:
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7. Non-Clinical Performance Data.
Flexural strength testing were conducted on the Zirconia material used for the ATLANTIS™ Crown according to the standards ISO 14704 and ASTM C1161. The results showed that the requirements of the standard ISO 6872 Dentistry Ceramic Materials were fulfilled. Fracture toughness, chemical solubility, radioactivity concentration and coefficient of thermal expansion were tested and completed according to the requirements specified in ISO 6872.
The material used for the ATLANTIS™ Crown and the manufacturing process is the same as used for the predicate device ATLANTIS™ Crown Abutment in Zirconia, K 110356. Therefore no additional biocompatibility testing has been performed.
8. Conclusion Regarding Substantial Equivalence
The ATLANTIS™ Crown is a patient-specific restorative device which is intended to be used with an ATLANTIS™ Abutment and an endosseous implant. The ATLANTIS™ Crown and the primary predicate, Cercon ht (K112152), can be delivered as a full contour crown or as a cut-back substructure onto which porcelain will be added by the customer. Thus, it can be concluded that the ATLANTIS™ Crown has the same intended use. incorporates the same fundamental technology, and has similar indications for use as the primary predicate device Cercon® ht (K112152).
Thus, it can be concluded that the proposed ATLANTIS™ Crown is substantially equivalent to the predicate devices.