FDA.reportPublic FDA data

N.A.

Primary DI
J011164000000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
164-000-00
Device description
LinguSil transfer matrix for indirect bonding, Polyvinylsiloxane) / For further information please visit our online-shop on our website www.dentaurum.de
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWLPROSTHESIS, LARYNGEAL (TAUB)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWLProsthesis, Laryngeal (Taub)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913537000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913537000MEMOSIL C.D.Heraeus Kulzer, Inc.1991-10-04ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011164000000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bite registration rimA schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships. Bite rims can be individually made or adjusted to one patient from preformed devices. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage: 18 - 25 °C / 64.4 - 77 °F

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011254000020ceraMotion®254-000-022026-07-25
J011254000100ceraMotion®254-000-102026-07-25
J011254000500ceraMotion®254-000-502026-07-25
J011254001020ceraMotion®254-001-022026-07-25
J011254001100ceraMotion®254-001-102026-07-25
J011254001500ceraMotion®254-001-502026-07-25
J011254002020ceraMotion®254-002-022026-07-25
J011254002100ceraMotion®254-002-102026-07-25
J011254002500ceraMotion®254-002-502026-07-25
J011254004020ceraMotion®254-004-022026-07-25
J011254004100ceraMotion®254-004-102026-07-25
J011254006020ceraMotion®254-006-022026-07-25
J011254006100ceraMotion®254-006-102026-07-25
J011254008020ceraMotion®254-008-022026-07-25
J011254008100ceraMotion®254-008-102026-07-25
J011254010020ceraMotion®254-010-022026-07-25
J011254010100ceraMotion®254-010-102026-07-25
J011254012020Triceram®254-012-022026-07-25
J011254014020Triceram®254-014-022026-07-25
J011254300020ceraMotion®254-300-022026-07-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00848253003122InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCEWL2023-11-03
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00848253003672InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003689InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003696InHealth TechnologiesFreudenberg Medical, LLCEWL2021-02-03
00848253003634InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-07-10
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00848253003399InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
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00848253003412InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
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00848253003436InHealth Technologies; Blom-SingerFreudenberg Medical, LLCEWL2019-06-07
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00848253001517InHealth Technologies; Blom-Singer; Dual ValveFreudenberg Medical, LLCEWL2018-01-01
00813307010647InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01
00813307010661InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01
00813307010685InHealth Technologies; Blom-Singer; AdvantageFreudenberg Medical, LLCEWL2018-01-01