Identity
- Trade Name
- Bone Management FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- BMA Kit, Master-Pin/ Master-Core FDA UDI
- Model / Reference
- BMA03 FDA UDI
- Description
- BMA Kit, Master-Pin/ Master-Core FDA UDI
Identifiers
- Catalog Number
- BMA03 FDA UDI
- Primary DI / UDI-DI
- E0HM79BMA031 FDA UDI
- 510(k) Number
- K130682 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Bone Management by Hager & Meisinger Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
- Dental Elevator Combo Set — SONTEC INSTRUMENTS, INC. · Class I
- Positioning Guide Full KIT — OSSTEM IMPLANT CO., LTD. · Class IIa
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- KLOCKNER — SOADCO, S.L. · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · Class I
- UniFit-Standard Internal Star Plastic Surgical Kit-Advanced — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class IIa
Cleared under the same submission
K130682 also covers:
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- MEITAC — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Master-Pin-Control — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Master-Pin-Control Basic — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Pin, dental — Hager & Meisinger Gesellschaft mit beschränkter Haftung
- Tac, dental — Hager & Meisinger Gesellschaft mit beschränkter Haftung
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI e997c22a-da86-4af8-9fca-04e5f7155c55 36 fields · synced May 30, 2026