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Device Explorer · FDA GUDID · GMDN 62481

Pliable-polymer dental regeneration membrane, non-bioabsorbable

A sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the

US‑registered devices358in commercial distribution
Companies7labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Osteogenics Biomedical Inc13939%
Zimvie Us Corp Llc12635%
Purgo Biologics Inc.4111%
Unicare Biomedical Inc.236%
Cowellmedi Co.,Ltd164%
Neoss Ab113%
Salvin Dental Specialties, Llc21%

Top labelers

CompanyDevicesShare
Osteogenics Biomedical Inc13939%
Zimvie Us Corp Llc12635%
Purgo Biologics Inc.4111%
Unicare Biomedical Inc.236%
Cowellmedi Co.,Ltd164%
Neoss Ab113%
Salvin Dental Specialties, Llc21%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Neoss Implant SystemOSSEOGUARD®Salvin Dental SpecialtiesPerforated TefguardPerforated Cytoflex Ti-enforcedCytoflex Ti-enforcedCytoflex Textured Tef-GuardCytoflex Smooth Tef-GuardCytoplast™ Non-Resorbable PTFE Barrier MembranesCytoplast™ Titanium-Reinforced PTFE MembranesCytoplast™ Non-Resorbable PTFE Barrier MembranesInnoGenic™ Non-resorbable Membrane-InnoGenic™ PTCYTOSHIELDTBS PTFE membraneOpenTexInnoGenic™ Non-resorbable Membrane-InnoGenic™ Wi

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NPKBarrier, Synthetic, Intraoral173
LYCBone grafting material, synthetic154
LYCBone Grafting Material, Synthetic79
NPKBarrier, synthetic, intraoral28

GMDN & GCC registration

  • GMDN code 62481 · non‑implantable
  • Single‑use 99% · sterile 99% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 286Width (Millimeter) · 286Height (Micrometer) · 54

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many pliable-polymer dental regeneration membrane, non-bioabsorbable products are registered in the US?

358 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Pliable-polymer dental regeneration membrane, non-bioabsorbable", from 7 companies. The largest labeler is Osteogenics Biomedical Inc with 39% of records.

Which FDA product codes apply?

NPK (Barrier, Synthetic, Intraoral), LYC (Bone grafting material, synthetic), LYC (Bone Grafting Material, Synthetic), NPK (Barrier, synthetic, intraoral)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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