FDA.reportPublic FDA data

MacBite

Primary DI
D1051217840
Brand
MacBite
Company
Surgimac LLC
Model
12178-4
Device description
MacBite Registration Material - 50ml, 4/Bx
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221668000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221668000Dental Impression MaterialChemoment Materials Co.,Ltd2022-08-08ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D1051217840PrimaryHIBCC0
D1051217849Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Regulatory Flags#

DUNS number
060635048
Device count
4
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D105VP9008MI4MacImpressVP-9008-MIVP9008MI2026-07-06
D1051013021MacSafe10-13021013022026-06-26
D1051013031MacSafe10-13031013032026-06-26
D1051013041MacSafe10-13041013042026-06-26
D1051013011MacSafe10-13011013012026-06-25
D105VP9008MI10MacImpress VP-9008-MI-12025-11-07
D105VP9007MI2MacImpress VP-9007-MI2025-09-25
D105VP9011MI2MacImpress VP-9011-MI2025-09-25
D105VP9007MI11MacImpress VP-9007-MI-12025-09-25
D105VP9007MI21MacImpress VP-9007-MI2025-09-25
D105VP9011MI11MacImpress VP-9011-MI-12025-09-25
D105VP9011MI21MacImpress VP-9011-MI2025-09-25
D105121781MacBite121782025-08-15
D105121789MacBite121782025-08-15
D1051217849MacBite12178-42025-08-15
D1057115XS0MacTouch 7115-XS2025-08-14
D1057115XSCS1MacTouch 7115-XS-CS2025-08-14
D1057116S0MacTouch 7116-S2025-08-14
D1057116SCS1MacTouch 7116-S-CS2025-08-14
D1057117M0MacTouch 7117-M2025-08-14

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