SMARTbuilder System (SB1)

Basic Information

• Brand Name: SMARTbuilder System (SB1)
• Primary DI: 08800000925158
• Version / Model: SM2W6127SE
• Company Name: Osstem Implant Co., Ltd.
• Labeler DUNS: 689051793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-16
• Public Version: 5
• Public Version Date: 2023-08-11
• Public Version Status: Update
• Public Device Record Key: acdd6426-99bc-4188-9c08-c8a00e1bcd69

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEY	Plate, Bone	Dental	872.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66252	Dental/maxillofacial surgical mesh, metal	An implantable, non-bioabsorbable, woven/knitted porous material made entirely of metal intended to provide temporary stabilization and support to a bone graft in the alveolar ridges, maxilla, or mandible. It is typically placed between the bone graft and soft tissue during dental or maxillofacial reconstruction and augmentation surgical procedures. Disposable devices associated with implantation may be supplied with the mesh.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800000925158	GS1

Premarket Submissions

Submission Number	Supplement Number
K130840	000