FDA.reportPublic FDA data

perFORM™

Primary DI
09358206000081
Brand
perFORM™
Company
ORTHOCELL LIMITED
Model
perf1520
Published
2023-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NPLBarrier, Animal Source, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPLBarrier, Animal Source, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201241000Striate+™Orthocell, Ltd.2021-01-11NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19358206000088PackageGS110In Commercial Distribution
09358206000081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1935820600008819358206000088
09358206000081093582060000819358206000081

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length20Millimeter
Width15Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
754598449
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09358206000043Remplir™ON-1522025-04-07
09358206000074Remplir™ON-4052025-04-07
19358206000040Remplir™ON-1522025-04-07
09358206000050Remplir™ON-2032025-04-07
09358206000067Remplir™ON-3042025-04-07
19358206000071Remplir™ON-4052025-04-07
09358206000098perFORM™perf20302023-04-18
09358206000104perFORM™perf30402023-04-18
09358206000005Striate+™OCG-1522021-04-27
09358206000012Striate+™OCG-2032021-04-27
09358206000029Striate+™OCG-3042021-04-27
09358206000036Striate+™OCG-4052021-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07610221017645Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
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07610221017669Bionnovation Gide XPGeistlich Pharma AGNPL2026-05-08
09421907331614Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331621Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331638Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331652Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331706Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331713Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331720Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331744Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331799Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331805Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331812Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331836Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
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06974944921490NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
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06974944921698NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921742NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16
06974944921759NeocirrusNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.NPL2026-04-16