FDA.reportPublic FDA data

PerioStom

Primary DI
00370275090168
Brand
PerioStom
Company
Forward Science Technologies LLC
Model
PerioStom 16ct
Device description
PerioStom Dental Dressing is an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief.
Published
2024-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
OLROral Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU
OLROral Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221428000PerioStom Dental DressingForward Science, LLC2022-12-22OLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00370275090168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00370275090168003702750901683702750901680370275090168

GMDN Terms#

Term, Definition table
TermDefinition
Clinical periodontal dressingA dental material intended to be used during periodontal procedures to facilitate periodontal tissue healing by providing mechanical, chemical, and/or thermal protection to wounded tissue after surgery or disease, and/or by functioning as a barrier for the prevention of bacterial infiltration in a periodontal pocket after root surface debridement (RSD) and/or planing and root scaling. Some types may adhere to teeth and gums and be used to secure medications, temporary prostheses, and loose teeth. It is available in various forms (e.g., gel in a syringe, fluid in a dispenser with mixing nozzle, substance mixed chairside into a pliable paste). After application, this device cannot be reused.

Regulatory Flags#

DUNS number
079212068
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
true
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370275123088OralID Fitted GlassesOralID Fitted Glasses 1ct2025-01-22
00370275123705OralID Over GlassesOralID Over Glasses 1ct2025-01-22
00370275092025FS Dispenser, StainlessStainless FS Dispenser 1ct2024-10-14
00370275091011FS DispenserFS Dispenser 1ct2024-02-21
00370275713050OrapeuticOrapeutic 5ct2024-02-14
00037027571305OrapeuticOrapeutic 5ct2024-02-14
00370275629047SalivaMAXSalivaMAX 30ct – 04 NDC2024-02-14
00370275850106BioStomBioStom 1ct2024-02-14
00370275850250BioStomBioStom 25ct2024-02-14
00370275850502BioStomBioStom 10ct2024-02-14
00370275123163OralIDFS-112016-10-03
00370275629030SalivaMAXSalivaMAX 30ct2016-10-03
00370275629122SalivaMAXSalivaMAX 120Ct2016-10-03
00370275629306SalivaMAXSalivaMAX 300Ct2016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
04714691213958VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2026-03-30
04714691213934VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-11-04
00850058790114RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790121RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790138G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790145G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790152G4Derm PlusGel4med, Inc.MGQ2025-10-17
04714691213903HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213910HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213897HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-22
04714691213859HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-06-12
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
04714691213705Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213712Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
04714691213682Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213699Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
00860013569907MuGardSoleva Pharma LLCOLR2025-02-28
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
04714691213552HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213569HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213576HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850443Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850450Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213521HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213538HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213545HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18