FDA.reportPublic FDA data

SiOxC

Primary DI
00850021883058
Brand
SiOxC
Company
Sioxmed, LLC
Model
SBC1, 1 Oz, 1 Unit
Catalog number
EDS-14001
Device description
SBC1 is a skin barrier emulsion indicated for management of dry, intact skin by maintaining a moist skin environment. SBC1 is comprised of a base cream (Prime Matter) mixed with milled silica-based fibers (SBF-1 and SBF-M1, described in MAF 3558), the same fibers used to make SiOxD Wound Matrix fibers (previously cleared in 510(k) submissions K222189, K232847, and K241660) to improve the texture of the cream. SBC1 is provided for prescription use only in 1- and 8-ounce jars for single patient use. The volumes offered in both container sizes are intended to be sufficient for multiple applications of the product to the treatment area(s) by a single patient.
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250890000SBC1 CreamSioxmed, LLC2026-01-12FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850021883058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850021883058008500218830588500218830580850021883058

GMDN Terms#

Term, Definition table
TermDefinition
Dry skin moisture barrier dressingA substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3365512209support@sioxmed.com

Regulatory Flags#

DUNS number
035978729
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850021883072SiOxD® ORSiOxD® OR Wound Matrix, 1gEDS-100502026-03-17
00850021883065SiOxCSBC1, 8 Oz, 1 UnitEDS-140022026-01-21
00850021883027SiOxCSiOxC Cream 1 Oz 1 UnitEDS-110162025-11-10
00850021883034SiOxCSiOxC Cream 8 Oz 1 UnitEDS-110192025-11-10
00850021883003SiOxD Wound MatrixSiOxD 0.3g 2.5in Round (0.35in) 1 Unit MylarEDS-100622025-11-10
00850021883041SiOxD Wound MatrixUniversal Combat Matrix (UCM) 0.7g 2.5in Round (0.EDS-130012025-11-10
10850021883000SiOxD Wound MatrixEDS-10058EDS-100582025-02-17

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