FDA.reportPublic FDA data

FotoDent® IBT 385 nm

Primary DI
E239D351201
Brand
FotoDent® IBT 385 nm
Company
Dreve Dentamid GmbH
Model
D35120
Catalog number
D35120
Device description
No
Published
2019-11-26
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
EBHMATERIAL, IMPRESSION TRAY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E239D351201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance positioning mould, basicA custom-made dental device in the form of an impression of a patient’s dentition intended to be used to position and hold in place a set of orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure; appliances are added after the mould has been manufactured. It is made of synthetic polymer materials and is manufactured from an oral cavity impression or oral scan for a specific patient. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
388000846
Device count
1
Premarket exempt
true
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
08800017902395Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902401Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902418Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902425Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
08800017902432Fish Bone Bite TraysDXM CO., LTDEBH2026-08-25
D14307560147448590Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBH2026-07-23
00840456224427JMUJMU DENTAL, INCEBH2026-07-20
00840456224434JMUJMU DENTAL, INCEBH2026-07-20
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09