Identity
- Trade Name
- BoneMedik-DM 1.0~2.0mm, 0.25g FDA UDI
- Generic Name
- Tungsten-weighted oesophageal dilator FDA UDI
- Device Name
- BoneMedik-DM is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate. FDA UDI
- Model / Reference
- 9718 FDA UDI
- Description
- BoneMedik-DM is a coralline hydroxyapatite and a more active tricalcium phosphate bone grafting material for dental and craniofacial usage. It is comprised of 60% silicon substituted hydroxyapatite and 40% [3-tricalcium phosphate. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806387897187 FDA UDI
- 510(k) Number
- K080772 FDA UDI
- FDA Product Code
- LYC FDA UDINPM FDA UDI
- GMDN Term
- Tungsten-weighted oesophageal dilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tungsten-weighted oesophageal dilator
BoneMedik-DM 1.0~2.0mm, 0.25g by Meta Biomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K080772 also covers:
- BeneMedik-DM, 0.1~0.3mm, 5cc — Meta Biomed, Inc.
- BeneMedik-DM, 0.3~0.5mm, 0.25cc — Meta Biomed, Inc.
- BeneMedik-DM, 0.5~1mm, 1cc — Meta Biomed, Inc.
- BoneMedik-DM 0.3~0.5mm, 0.25g — Meta Biomed, Inc.
- BoneMedik-DM 0.3~0.5mm, 1.0g — Meta Biomed, Inc.
- BoneMedik-DM 0.3~0.5mm, 2.0g — Meta Biomed, Inc.
- BoneMedik-DM 0.5~1.0mm, 0.5g — Meta Biomed, Inc.
- BoneMedik-DM 0.5~1.0mm, 1.0g — Meta Biomed, Inc.
- BoneMedik-DM 1.0~2.0mm, 0.5g — Meta Biomed, Inc.
- BoneMedik-DM 1.0~2.0mm, 1.0g — Meta Biomed, Inc.
- BoneMedik-DM, 0.1~0.3mm, 0.25cc — Meta Biomed, Inc.
- BoneMedik-DM, 0.1~0.3mm, 0.25g — Meta Biomed, Inc.
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
- Manufacturer
- Meta Biomed, Inc.
Sources (1)
- FDA UDI 2de0bacd-8ff8-4fee-bb53-8ff1685a00d3 34 fields · synced Jun 1, 2026