FDA.reportPublic FDA data

Ceramill Splintec

Primary DI
D709760533
Brand
Ceramill Splintec
Company
Merz Dental GmbH
Model
Ceramill Splintec 98x20 N/US
Catalog number
760533
Device description
Ceramill Splintec 98x20 N/US
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K134015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K134015000M-PM-DISCMerz Dental GmbH2014-04-11MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D709760533PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Removable dental occlusal splint, custom-madeA rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height20Millimeter
Outer Diameter98Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+494381403411claudia.bobrowski@merz-dental.de

Regulatory Flags#

DUNS number
324914910
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7091019183M-PM DiscM-PM Disc, PMMA-Disc, shade BL4 translucent ZIR th10191832016-09-24
D7091019186M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent ZIR thi10191862016-09-24
D7091019187M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent ZIR thi10191872016-09-24
D7091019188M-PM DiscM-PM Disc, PMMA-Disc, shade A3.5 translucent ZIR t10191882016-09-24
D7091019189M-PM DiscM-PM Disc, PMMA-Disc, shade A4 translucent ZIR thi10191892016-09-24
D7091019236M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent thickne10192362020-04-07
D7091019237M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent thickne10192372020-04-07
D7091019238M-PM DiscM-PM Disc, PMMA-Disc, shade B1 translucent thickne10192382020-04-07
D7091019239M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10192392020-04-07
D7091019240M-PM DiscM-PM Disc, PMMA-Disc, shade A1 translucent thickne10192402020-04-07
D7091019420M-PM DiscM-PM Disc, PMMA-Disc, shade A1 translucent thickne10194202019-12-05
D7091019421M-PM DiscM-PM Disc, PMMA-Disc, shade A2 translucent thickne10194212019-12-05
D7091019422M-PM DiscM-PM Disc, PMMA-Disc, shade A3 translucent thickne10194222019-12-05
D7091019423M-PM DiscM-PM Disc, PMMA-Disc, shade A3,5 translucent thick10194232019-12-05
D7091019424M-PM DiscM-PM Disc, PMMA-Disc, shade A4 translucent thickne10194242019-12-05
D7091019425M-PM DiscM-PM Disc, PMMA-Disc, shade B1 translucent thickne10194252019-12-05
D7091019426M-PM DiscM-PM Disc, PMMA-Disc, shade B2 translucent thickne10194262019-12-05
D7091019427M-PM DiscM-PM Disc, PMMA-Disc, shade B3 translucent thickne10194272019-12-05
D7091019428M-PM DiscM-PM Disc, PMMA-Disc, shade B4 translucent thickne10194282019-12-05
D7091019429M-PM DiscM-PM Disc, PMMA-Disc, shade C1 translucent thickne10194292019-12-05

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