(261 days)
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No
The document describes a resorbable bone graft matrix and does not mention any computational or algorithmic components.
No.
The device is a resorbable bone graft matrix used for various dental surgical procedures to aid in bone regeneration and wound healing, not to treat a disease or condition itself.
No
The device is a resorbable bone graft matrix used for surgical procedures related to bone regeneration and healing, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, resorbable bone graft matrix comprised of collagen and hydroxylapatite, supplied in physical forms (cubes and strips). There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) for surgical procedures related to bone grafting and tissue regeneration in the periodontal and maxillofacial areas.
- Device Description: The device is a resorbable bone grafting substitute made of collagen and hydroxylapatite, designed to be implanted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on in vitro samples.
Therefore, OsteoTape® is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with OsteoTape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue generation (GTR). Titanium tack-screws may be used to immobilize OsteoTape®
Product codes
NPM
Device Description
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape) in various preformed shapes, is a resorbable bone grafting substitute comprised of highly purified Type I bovine collagen, used as a carrier derived from bovine Achilles tendon, combined with crystals of the product OsteoGen®, a synthetic bioactive resorbable graft of the non-ceramic hydroxylapatite category. The product is supplied in cubes and strip forms, sterile, and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
periodontal and maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Image /page/0/Picture/1 description: The image shows the logo for IMPLADENT LTD. The logo consists of a symbol on the left and the company name on the right. The symbol is a geometric shape with a square in the center and lines extending from each side. The text is in a bold, sans-serif font.
Advancing the Science of Implantology
Avenue, Holliswood NY 11423
K0910794
510(K) SUMMARY
Type of Submission:
Traditional Premarket Notification 510(k) 21 CFR 807.92 March 19, 2009
Submitted by:
ﭘﺮ
くな
DEC 1 0 2009
Impladent Ltd. 198-45 Foothill Avenue Holliswood NY 11423-1611
Contact Person:
Maurice Valen President; Director of R&D Phone: 718 465-1810 Fax: 718 464-9620 Email: maurice(@impladentItd.com or ginnyv@earthlink.net
Under section 21 CFR 807.95, selected pages and/or sections have been marked as "CONFIDENTIAL"; any request for same under
Establishment Registration: 2431866
| Common Name: | |
|---|---|
| Proprietary Name: | |
| Classification: | |
| Classification Regulation: | |
| Product Code: | |
| Review Panel: |
Bone Graft Material OsteoTape® Class II 21 CFR 872.3930 LYC - Bone Grafting Material, Synthetic Dental
Confidentiality:
Freedom of Information Act should be purged.
Purpose of Submission: Evidence herein is submitted to establish substantial equivalence for the product OsteoTape® to devices marketed in interstate commerce prior to May 28, 1976, and to legally marketed predicate devices cleared via the 510(k) process.
Performance Standards: No performance standards have been established under Section 514
- Special Controls: Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices
1
Impladent Ltd. OsteoTape® 510(k) Summary
1
March 19, 2009 SECTION 5
DEVICE DESCRIPTION
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape) in various preformed shapes, is a resorbable bone grafting substitute comprised of highly purified Type I bovine collagen, used as a carrier derived from bovine Achilles tendon, combined with crystals of the product OsteoGen®, a synthetic bioactive resorbable graft of the non-ceramic hydroxylapatite category. The product is supplied in cubes and strip forms, sterile, and for single use only.
INDICATIONS FOR USE
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with OsteoTape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue regeneration (GTR). Titanium tack-screws may be used to immobilize OsteoTape®
CONFORMANCE WITH PERFORMANCE STANDARDS
Voluntary standards to which OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, complies include:
| ASTM F2212-08e1 | Standard Guide for Characterization of Type I Collagen as Starting
Material for Surgical Implants and Substrates for Tissue Engineered
Medical Products (TEMPs) |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F1185-03 | Standard Specification for Composition of Hydroxylapatite for
Surgical Implants · |
| ANSI/AAMI/
ISO 11137 | Sterilization of Health Care Products- Radiation Sterilization |
| AAMI TIR 27 | Sterilization of Health Care Products - Radiation Sterilization-
Substantiation of 25kGy as a sterilization dose - Method VDmax |
For Sterilization and Biocompatibility standards used, please refer to Sections 14 and 15.
2
Impladent Ltd. OsteoTape® 510(k) Summary
March 19, 2009 SECTION 5
SPECIAL CONTROLS
A Special Control that applies to OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, is the Guidance for Industry and FDA Staff: Class II Special Control Guidance Document: Dental Bone Grafting Materials, issued on April 28, 2005.
SUMMARY/COMPARISON OF TECHNICAL CHARACTERISTICS
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, and its predicate devices have the same technology characteristics according to specified standards. In particular, OsteoTape® and its predicate devices are similar with respect to intended use, material application, structure, material composition, characterization and similar sizes.
SAFETY
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix, has been evaluated as to its safety and effectiveness by a number of standardized tests to assess its safety, viral inactivation, and biocompatibility in vivo and in vitro, and is confirmed in the medical literature as being safe and effective for a variety of dental applications.
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings spread and head turned to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Mr. Maurice Valen President Director of R&D Impladent, Limited 198-45 Foothill Avenue Holliswood, New York 11423-1611
Re: K090794
Trade/Device Name: OsteoTapeTM Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Codes: NPM Dated: December 2, 2009 Received: December 3, 2009
Dear Mr. Valen:
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.
DEC 1 0 2009
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.
4
Page 2 – Mr. Valen
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
for
Sue- Renner, D.D.S.
Susan Runner, D.D.S Acting 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: K090794
Device Name: OsteoTape®
Indications for Use:
OsteoTape®, an OsteoGen® Collagen Resorbable Bone Graft Matrix (OsteoTape), is indicated for periodontal and maxillofacial use in surgical procedures, to be placed in sockets for the insertion of dental implants after healing; for the containment of bone graft granules after tooth extraction; repair of periodontal infrabony defects and ridge preservation; buccal onlay grafting in conjunction with Osteo Tape® granules and/or strips; to augment the sinus; and, for guided bone regeneration (GBR) techniques. The non-ceramic material can also be used for wound healing post-dental implant surgery and over titanium implant devices if primary closure is not attainable for guided tissue regeneration (GTR). Titanium tack-screws may be used to immobilize OsteoTape®
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter NO (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ke. Muly for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090794
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