(78 days)
Not Found
No
The device description and intended use focus on the material properties and application of a synthetic bone graft substitute, with no mention of AI or ML.
No
The device, OSSAPLAST DENTAL, is described as a synthetic, implantable, resorbable, radiopaque βtricalcium phosphate (β-TCP) ceramic in granulate form used for filling, augmenting, or reconstructing defects. Its function appears to be that of a structural or regenerative material rather than a device that provides a therapeutic effect through energy, physiological modulation, or direct treatment of a disease beyond filling a defect. It assists in reconstruction and regeneration, which are outcomes of therapy, but the device itself is a material that enables these processes.
No.
The device is a synthetic, implantable, resorbable ceramic material used for filling, augmenting, or reconstructing defects. Its intended use is for treatment, not for diagnosing any condition.
No
The device description clearly states that OSSAPLAST DENTAL is a synthetic, implantable, resorbable, radiopaque βtricalcium phosphate (β-ΤCP) ceramic in granulate form, supplied in sealed glass vials. This describes a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material for filling, augmenting, or reconstructing bony defects within the body (specifically the oro-maxillofacial region). This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The device is a synthetic, implantable, resorbable ceramic in granulate form. This is a physical material intended to be placed within the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue) to provide information about a patient's health status, disease, or condition.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide diagnostic information. OSSAPLAST DENTAL is used in vivo (within the body) for structural support and regeneration.
N/A
Intended Use / Indications for Use
OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for GBR.
Product codes (comma separated list FDA assigned to the subject device)
LPK, LYC
Device Description
OSSAPLAST DENTAL is a synthetic, implantable, resorbable, radiopaque βtricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of purephase β-ΤCP [Саз(РОд)½] and is csteoconductive, with high interconnecting porosity. OSSAPLAST DENTAL is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oro-maxillofacial region
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
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
K05337 Lt
Image /page/0/Picture/1 description: The image shows the word "OSSACUR" in a bold, sans-serif font. A thick, black arc is positioned above and below the word, creating a circular enclosure around it. The arcs are symmetrical and curve upwards, adding a sense of visual containment to the text.
FEH ! 1 2006
510(K) Summary
A. Submitter Information
| Submitter's Name: | OSSACUR® AG |
|---|---|
| Address: | Benzstrasse 2 |
| D-71720 | |
| Oberstenfeld, Germany | |
| Phone Number: | (+49) 7062 9404-0 |
| Fax Number: | (+49) 7062 9404-20 |
| Contact Person: | Arne Briest |
| Date of Preparation: | November 30, 2005 |
B. Device Name
| Trade Name: | OSSAPLAST™ DENTAL |
|---|---|
| Common/Usual Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material |
| §872.3930 (Product Code: LPK) |
C. Predicate Devices
| Trade Name: | calc-i-oss® (K042583) |
|---|---|
| Trade Name: | Cerasorb® DENTAL (K051443) |
D. Device Description
OSSAPLAST DENTAL is a synthetic, implantable, resorbable, radiopaque βtricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of purephase β-ΤCP [Саз(РОд)½] and is csteoconductive, with high interconnecting porosity.
1
OSSAPLAST DENTAL is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.
E. Intended Use
OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for GBR.
F. Technological Characteristics Summary
OSSAPLAST DENTAL does not incorporate any new technological characteristics as compared to the predicate devices. OSSAPLAST DENTAL and the predicate devices are made from the same material (pure-phase β-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade β-TCP to be used in surgical implant applications. OSSAPLAST DENTAL is substantially equivalent to the predicate devices in regard to structure, porosity, form, packaging, sterility, and biocompatibility.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP 1 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ossacur AG C/O Ms. Kristi Kistner Pacific Otter Works, Incorporated 975 Veronics Springs Road Santa Barbara, California 93105
Re: K053374
Trade/Device Name: OSSAPLAST DENTAL™ Bone Grafting Material Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 30, 2005 Received: December 5, 2005
Dear Ms. Kistner:
This letter corrects our substantially equivalent letter of February 21, 2006.
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 (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 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.
3
Page 2 - Ms. Kistner
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I DTS issuained on that your device complies with other requirements mean mat ITDA nas made a deceminations administered by other Federal agencies. of the Act of ally 1 oderal bake and sequirements, including, but not limited to: registration Tour must comply with an the Free Stop (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 807), laceming (21 CFR Part 820), and if requirents as set form in the quality ison control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section I ins letter will anow you to continue manage of substantial equivalence of your device to 510(K) premailted 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 (http://www.fda.gov/cdrh/organiz.html#0C for OC organization structure). Also, please (fittp://www.laa.gow.caring by reference to premarket notification" (21 CFR note the regulation entired, "Thister general information on your responsibilities under the r at 607.97). Tourinay 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/dsma/dsmamain.html
Sincerely yours,
C. Arlen Price, Ph.D.
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
4
SECTION I-E.
Statement of Indications for Use
510(k) Number (if known): ڀر ڇڏڪوڪو
Device Name: OSSAPLAST™ DENTAL Bone Grafting Material
Indications for Use:
OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for GBR.
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 Gunner
rology, General Hospital,
and Dental Devices
Page 1 of 1OSSACUR® AG
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