FDA.reportPublic FDA data

Fixtemp C&B

Primary DI
E239D503931
Brand
Fixtemp C&B
Company
Dreve Dentamid GmbH
Model
D50393
Catalog number
D50393
Device description
No.
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102917000FIXTEMP C&BExacta Dental Direct, Inc.2011-06-17EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E239D503931PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49230388070info@dreve.de
+49230388070dentamid@dreve.de

Regulatory Flags#

DUNS number
388000846
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E239D359501FotoDent® TryInD35950D359502026-02-27
E239D382341Odontosil 2K LackD38234D382342022-08-19
E239D50381501Odontosil 50 ShoreD5038150D50381502022-08-19
E239D50381601Odontosil 60 ShoreD5038160D50381602022-08-19
E239D50382271Odontosil 60 ShoreD5038227D50382272022-08-19
E239D50382291Odontosil 50 ShoreD5038229D50382292022-08-19
E239D361501Primeprint Direct AlignerD36150D361502025-11-25
E239D49701X41Mixing tipsD49701X4D49701X42025-08-13
E239D496041TipsD49604D496042025-07-21
E239D49701X61Mixing tipsD49701X6D49701X62025-07-18
E239D4248X7SQ1Drufosoft®D4248X7SQD4248X7SQ2025-03-31
E239D4248X8S1Drufosoft®D4248X8SD4248X8S2025-03-31
E239D4248X8SQ1Drufosoft®D4248X8SQD4248X8SQ2025-03-31
E239D4248X9S1Drufosoft®D4248X9SD4248X9S2025-03-31
E239D424901S1Drufosoft®D424901SD424901S2025-03-31
E239D424901SQ1Drufosoft®D424901SQD424901SQ2025-03-31
E239D42531S1Drufosoft®D42531SD42531S2025-03-31
E239D4300S1BioBleach® softD4300SD4300S2025-03-31
E239D4248X3SQ1Drufosoft®D4248X3SQD4248X3SQ2025-03-28
E239D4248X4S1Drufosoft®D4248X4SD4248X4S2025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07506338322478Nic ToneMDC DENTALEBG2026-07-20
07506338322485VIVIDMDC DENTALEBG2026-07-20
07506338322492VIVIDMDC DENTALEBG2026-07-20
07506338322508VIVIDMDC DENTALEBG2026-07-20
07506338322515VIVIDMDC DENTALEBG2026-07-20
07506338322522VIVIDMDC DENTALEBG2026-07-20
07506338322539VIVIDMDC DENTALEBG2026-07-20
07506338322546VIVIDMDC DENTALEBG2026-07-20
07506338322553VIVIDMDC DENTALEBG2026-07-20
07506338322560VIVIDMDC DENTALEBG2026-07-20
07506338322577Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322584Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322591Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322614Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
07506338322973Nic Tone, MDC DentalMDC DENTALEBG2026-07-20
E235DD16A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A35MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16A3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16B3MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL3ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BL4MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09
E235DD16BLML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-07-09