Identity
- Trade Name
- Integra® Miltex® Helimend® Advanced FDA UDI
- Generic Name
- Dental/maxillofacial soft-tissue biomatrix implant, animal-derived FDA UDI
- Device Name
- HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks. FDA UDI
- Model / Reference
- 62206 FDA UDI
- Description
- HeliMEND and HeliMEND Advanced absorbable collagen membranes are made from purified bovine tendon. These collagen products provide wound stabilization and create space during guided tissue regeneration procedures where a longer absorption rate is desired. HeliMEND Advanced collagen membrane is absorbed within 18 weeks. FDA UDI
Identifiers
- Catalog Number
- 62206 FDA UDI
- Primary DI / UDI-DI
- 10381780038511 FDA UDI
- 510(k) Number
- K992216 FDA UDI
- FDA Product Code
- LYC FDA UDI
- GMDN Term
- Dental/maxillofacial soft-tissue biomatrix implant, animal-derived 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Dental/maxillofacial soft-tissue biomatrix implant, animal-derived
Integra® Miltex® Helimend® Advanced by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial soft-tissue biomatrix implant, animal-derived.
- SALVIN ORAMEM — SALVIN DENTAL SPECIALTIES, LLC · Class II
- ORAMEM-SUS-15X20 — SALVIN DENTAL SPECIALTIES, LLC · Class II
- ORAMEM-SUS-30X40 — SALVIN DENTAL SPECIALTIES, LLC · Class II
- Geistlich Mucograft® Seal — Geistlich Pharma AG · Class II
- R.T.R Membrane — Septodont · Class II
- Geistlich Fibro-Gide® — Geistlich Pharma AG · Class II
- Geistlich Mucograft® Seal — Geistlich Pharma AG · Class II
- COPIOS® Pericardium Membrane — Tutogen Medical GmbH · Class II
Cleared under the same submission
K992216 also covers:
- BioMend® Extend™ Absorbable Collagen Membrane — Integra Lifesciences Corp.
- BioMend® Extend™ Absorbable Collagen Membrane — Integra Lifesciences Corp.
- BioMend® Extend™ Absorbable Collagen Membrane — Integra Lifesciences Corp.
- HeliMend® Advanced — Integra Lifesciences Corp.
- Integra® Miltex® Helimend® Advanced — Integra Lifesciences Corp.
- ORAMEM-SUS-15X20 — SALVIN DENTAL SPECIALTIES, LLC
- ORAMEM-SUS-20X30 — SALVIN DENTAL SPECIALTIES, LLC
- ORAMEM-SUS-30X40 — SALVIN DENTAL SPECIALTIES, LLC
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
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI c79f94f1-0ee0-435a-b461-f0cbcc5d807a 38 fields · synced Jun 1, 2026