SOCKET GRAFT

K113049 · Steiner Laboratories · LYC · Jan 27, 2012 · Dental

Device Facts

• Record ID: K113049
• Device Name: SOCKET GRAFT
• Applicant: Steiner Laboratories
• Product Code: LYC · Dental
• Decision Date: Jan 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.

Device Story

Socket Graft is a dual-phase calcium phosphate biocement kit containing Socket Seal barrier membrane. Clinician wets powder with sterile water to form putty; fills dental extraction sockets with all walls remaining; covers with Socket Seal. Socket Seal is a nonporous, semi-rigid polyethylene foam sheet. Device stabilizes bone graft, provides space maintenance for regenerative healing. Socket Graft resorbs in 12-14 weeks. Used in dental clinics by dentists/oral surgeons. Output is physical bone regeneration scaffold. Benefits patient by facilitating bone growth in extraction sites, enabling subsequent implant placement.

Clinical Evidence

Bench testing only. Comparative analysis provided for trace impurities (USP 34), particle presence, Ca/P ratio, pH, volumetric porosity, and solubility. No clinical trials performed; resorption timing and clinical efficacy supported by literature review of predicate device (K052493) performance in 100-patient study.

Technological Characteristics

Socket Graft: Dual-phase calcium phosphate biocement with sodium carboxymethylcellulose (CMC). Socket Seal: Nonporous, closed-cell polyethylene foam. Sterilization: Gamma radiation. Form factor: 1.5 cc single-use syringes (graft) and semi-rigid sheets (seal).

Indications for Use

Indicated for dental extraction sockets with all walls remaining (Socket Graft) and as a space-maintaining barrier over bone grafts or extraction sockets in the maxilla and mandible (Socket Seal).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Socket Graft (K052493)
• EquivaBone Osteoinductive Bone Graft (K090855)
• CalMatrix Calcium Sulfate Bone Graft (K041324)
• IMTEC BioBarrier Membrane (K974752)
• Tefgen-LS (K965205)

Submission Summary (Full Text)

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510(k) Summary

K113049

# SUMMARY REPORT

JAN 2 7 2012

SUBMITTED BY

Gregory Gene Steiner CEO STEINER LABORATORIES Kapolei, HI 96707 808 689 1710

01/15/2012

This summary of 510k substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92. Socket Graft is intended to be marketed as a kit containing Socket Graft bone grafting material and a barrier membrane titled Socket Seal.

#### CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME for Socket Graft

| Classification Name: | Bone grafting material, synthetic |
|-------------------------|-----------------------------------|
| Common/Usual Name: | Bone grafting material |
| Product Classification: | LYC |
| Proprietary Name: | SOCKET GRAFT |

## CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME for Socket Seal

| Classification Name: | Barrier, Synthetic, Oral |
|-------------------------|--------------------------|
| Regulation description: | Bone grafting material |
| Common/Usual Name: | Barrier, Synthetic, Oral |
| Product Classification: | NPK |
| Proprietary Name: | SOCKET SEAL |

#### SOCKET GRAFT grafting material is substantially equivalent to:

- 1) Socket Graft K052493
- 2) EquivaBone Osteoinductive Bone Graft K090855
- 3) CalMatrix Calcium Sulfate Bone Graft K041324

#### SOCKET SEAL is substantially equivalent to:

- 1) IMTEC BioBarrier Membrane K974752 2) Tefgen-LS K965205

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#### DEVICE DESCRIPTION

SOCKET GRAFT is intended to regenerate bone in dental extraction sockets. SOCKET GRAFT is dual phase calcium phosphate biocement that is wetted by sterile water to a putty consistency. Extraction sockets are filled with SOCKET GRAFT and covered by the enclosed Socket Seal. SOCKET GRAFT is fully resorbed in 12-14 weeks resulting the extraction socket. SOCKET GRAFT is supplied in sterile, single use 1.5 cc syringes.

Socket Seal is a closed cell, medical grade, polyethylene foam material that is a nonporous, biocompatible semi-rigid sheet. Socket Seal is designed to stabilize, support and protect bone graft material and provide space maintenance for regenerative healing.

#### INDICATIONS FOR USE

SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining.

Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.

#### PERFORMANCE TESTING:

In comparison to the predicate device Socket Graft K052493comparison summary: Non clinical testing.

| | Socket Graft predicate K052493 | Socket Graft K113049 |
|---------------------------------------------------------------------------------------|--------------------------------|----------------------|
| Trace impurities analysis<br>Reference US pharmacopeia 34<br>specification NMT 20 PPM | pass | pass |
| Particles | none | none |
| Ca/P ratio | equivalent | equivalent |
| Ph | 7.2 | 7.4 |
| volumetric<br>porosity | 25% | non porous |
| Solubility @ 20C | non soluble | non soluble |

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The proposed device Socket Graft K113049 differs in composition only by the addition of sodium salt of carboxymethylcellulose.

The sodium salt of carboxymethylcellulose used in Socket Graft conforms to the GRAS classification 21 CFR 182.1745 with the following analysis:

| reference | test results |
|----------------------------------|------------------|
| 99.5% by dry weight | 99.8 |
| max substitution 0.95 | 0.77 |
| minimum viscosity 25 centipoises | 3100 centipoises |

Predicate devices EquivaBone Osteoinductive Bone Graft and CalMatrix Calcium Sulfate Bone Graft both contain comparable amounts of carboxymethylcellulose and both of these predicate devices have used carboxymethylcellulose to increase the viscosity of their graft material in the same manner as the proposed device Socket Graft K113049 . Carboxymethylcellulose has been shown to resorb in 12 weeks in vivo in the following reference "Carboxymethylcellulose-stabilized collagenous rhOP-1 device-a novel carrier biomaterial for the repair of mandibular continuity defects. Wang H et al".

The predicate device Socket Graft K052493 was shown to fully resorb in 12-14 weeks. The timing of implant placement for Socket Graft K113049 is based on published research for the predicate device Socket Graft K052493. In the published research article "The healing socket and socket regeneration. Compend Contin Educ Dent. 2008 Mar;29(2):114-6, 118, 120-4". One Hundred implants were placed on a protocol of 6 weeks for incisors and bicuspids and 8 weeks for molars. All one hundreds implants integrated and all implants were in function 3 years after placement. Therefore, the earliest time point for implant placement in sockets grafted with Socket Graft K113049 is 8 weeks.

#### Substantial Equivalence:

Socket graft grafting material and Socket Seal shares indications and design principles with the following predicate devices:

| Device name | Proposed Device | Predicate device #1 | Predicate Device #2 | Predicate Device #3 |
|--------------|---------------------------------------------|---------------------------------------------|--------------------------------------------|--------------------------------------------------|
| | Socket Graft | Socket Graft | EquivaBone<br>Osteoinductive Bone<br>Graft | CalMatrix Calcium<br>Sulfate Bone Graft |
| 510 K number | K113049 | K052493 | K090855 | K041324 |
| Intended use | SOCKET GRAFT is a<br>bone grafting material | SOCKET GRAFT is a<br>bone grafting material | EquivaBone is an<br>osteoinductive bone | used to treat multiple<br>types of maxillary and |

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| | indicated for use in<br>dental extraction<br>sockets that have all<br>walls remaining. | indicated for use in<br>dental extraction<br>sockets. | graft substitute that<br>is resorbed and<br>replaced with new<br>bone during the healing<br>process. It is intended<br>for use to fill bony<br>voids or gaps of the<br>skeletal system of the<br>extremities, spine<br>(i.e.posterolateral<br>spine) and pelvis that<br>are not intrinsic to the<br>stability of the bony<br>structure. These voids<br>or gaps may result from<br>natural occurring bone<br>disease, traumatic<br>injury<br>or surgical intervention. | mandibular osseous<br>and periodontal defects<br>such as:<br>Intrabony/infrabony<br>defects, furcation<br>defects, recession<br>defects,<br>dehiscence/fenestratio<br>n defects (natural teeth<br>and prosthetic root<br>form implants),<br>extraction socket (ridge<br>preservation) defects,<br>ridge augmentation<br>defects, sinus lift<br>defects, endodontic<br>bony defects |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | A dual phase calcium<br>phosphate biocement<br>plus carboxymethyl<br>cellulose<br>(CMC) that is wetted by<br>sterile water to a putty<br>consistency. | A dual phase calcium<br>phosphate biocement<br>that is wetted by<br>sterile water to a paste<br>consistency | Synthetic calcium<br>phosphate,<br>carboxymethyl<br>cellulose<br>(CMC) and<br>demineralized bone<br>matrix (DBM) that is<br>wetted by sterile water<br>to a putty consistency. | A calcium sulfate<br>material that contains<br>approximately 10% of<br>pharmaceutical grade<br>sodium<br>carboxymethylcellulose<br>(CMC) that is wetted by<br>sterile water to a putty<br>consistency. |
| Design | Powder, water | Powder, water | Powder, water | Powder, water |
| Sterile/<br>non sterile | Sterile | sterile | Sterile | Sterile |
| Sterilization<br>method | gamma | gamma | gamma | gamma |
| Biocompatible | Yes | yes | yes | yes |
| Resorbable/<br>Nonresorbable | resorbable | resorbable | resorbable | resorbable |

## PREDICATE DEVICES for Socket Seal

:

| Device name | Proposed Device | Predicate Device #1 | Predicate Device#2 |
|--------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Socket Seal | IMTEC BioBarrier<br>Membrane | Tefgen-LS |
| 510 K number | K113049 | K974752 | K965205 |
| Intended use | A temporary<br>implantable material<br>intended for use in the<br>oral cavity to be used as | A temporary implantable<br>material intended to be<br>used in the oral cavity as a<br>space maintaining barrier | A implant material which is<br>intended to be used in the<br>oral cavity as a temporary<br>space making barrier over |

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| | a space maintaining<br>barrier over bone and<br>connective tissue.<br>Socket Seal is indicated<br>for use over bone<br>grafts. Socket Seal in<br>indicated for use over<br>extraction sockets in<br>the maxilla and<br>mandible. | over bone. Use in<br>augmentation around<br>implants placed in<br>immediate extraction<br>sockets and around<br>implants placed in delayed<br>extraction sockets and<br>should be used in<br>combination with space-<br>making bone graft<br>material. | bone or other tissue. |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Material | polyethylene | polyethylene | polyethylene |
| Design | sheets | sheets | sheets |
| Sterile/non<br>sterile | Sterile | Sterile | Sterile |
| Sterilization<br>method | gamma | Not specified | Not specified |
| Biocompatible | Yes | yes | yes |
| Resorbable/<br>Nonresorbable | nonresorbable | nonresorbable | nonresorbable |
| porosity | nonporous | nonporous | nonporous |

## Conclusion (statement of equivalence)

The data submitted in this 510(k) supports substantial equivalence of Socket Graft and Socket Seal to the following aforementioned commercially marketed devices.

Substantial equivalence is based on the indications for use, product design and configuration, and materials used. The intended use of Socket Graft K113049 is the same as Socket Graft K052493, and the materials used are the same as those found in Socket Graft K052493 with the exception of the addition of carboxymethyl cellulose(CMC). Socket The comparative analysis demonstrates the substantial equivalence of Socket Graft and Socket Seal to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Gregory G. Steiner CEO STEINER LABORATORIES 590 Farrington Highway, #524 Suite 132 Kapolei, Hawaii 96707

Re: K113049

Trade/Device Name: Socket Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: January 15, 2012 . Received: January 23, 2012

Dear Mr. Steiner:

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.

JAN 2 7 2012

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#### Page 2 - Mr. Steiner

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

G for Anthony Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement

| 510(k) Number (if known) | K113049, Socket Graft, January 15 2012 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Socket Graft |
| Indications for Use | SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible." |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

Prescription Use_ X (Per 21 CFR 801. 109)

Over-The-Counter Use_

Susan Kunne
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KII13049 510(k) Number: __