FDA.reportPublic FDA data

dentaform®

Primary DI
J011878015220
Brand
dentaform®
Company
DENTAURUM GmbH & Co.KG
Model
878-015-22
Device description
dentaform® Snap Band, Tooth 16, Size 15/Roth 22
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
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECMBAND, PREFORMED, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011878015220PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Contacts#

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

Regulatory Flags#

DUNS number
315427286
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011130131000N.A.130-131-002020-08-28
J011130137000N.A.130-137-002020-08-28
J011130138000N.A.130-138-002020-08-28
J011130324000N.A.130-324-002020-08-28
J011130634000N.A.130-634-002020-08-28
J011262411100Carmen®262-411-102016-09-15
J011262412100Carmen®262-412-102016-09-15
J011262415100Carmen®262-415-102016-09-15
J011262421100Carmen®262-421-102016-09-15
J011262422100Carmen®262-422-102016-09-15
J011262423100Carmen®262-423-102016-09-15
J011262424100Carmen®262-424-102016-09-15
J011262431100Carmen®262-431-102016-09-15
J011262432100Carmen®262-432-102016-09-15
J011262433100Carmen®262-433-102016-09-15
J011262434100Carmen®262-434-102016-09-15
J011262442100Carmen®262-442-102016-09-15
J011262443100Carmen®262-443-102016-09-15
J011262444100Carmen®262-444-102016-09-15
J011262450100Carmen®262-450-102016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456206225JMUJMU DENTAL, INCECM2026-06-25
00840456206232JMUJMU DENTAL, INCECM2026-06-25
08033707035763LEONE SPALEONE SPAECM2020-11-11
08033707035770LEONE SPALEONE SPAECM2020-11-11
08033707035787LEONE SPALEONE SPAECM2020-11-11
08033707035794LEONE SPALEONE SPAECM2020-11-11
08033707035800LEONE SPALEONE SPAECM2020-11-11
08033707035817LEONE SPALEONE SPAECM2020-11-11
08033707035824LEONE SPALEONE SPAECM2020-11-11
08033707035831LEONE SPALEONE SPAECM2020-11-11
08033707035848LEONE SPALEONE SPAECM2020-11-11
08033707035855LEONE SPALEONE SPAECM2020-11-11
08033707035862LEONE SPALEONE SPAECM2020-11-11
08033707035879LEONE SPALEONE SPAECM2020-11-11
08033707035886LEONE SPALEONE SPAECM2020-11-11
08033707035893LEONE SPALEONE SPAECM2020-11-11
08033707035909LEONE SPALEONE SPAECM2020-11-11
08033707035916LEONE SPALEONE SPAECM2020-11-11
08033707035923LEONE SPALEONE SPAECM2020-11-11
08033707035930LEONE SPALEONE SPAECM2020-11-11
08033707035947LEONE SPALEONE SPAECM2020-11-11
08033707035954LEONE SPALEONE SPAECM2020-11-11
08033707035961LEONE SPALEONE SPAECM2020-11-11
08033707035015LEONE SPALEONE SPAECM2020-11-10
08033707035022LEONE SPALEONE SPAECM2020-11-10
08033707035039LEONE SPALEONE SPAECM2020-11-10
08033707035046LEONE SPALEONE SPAECM2020-11-10
08033707035053LEONE SPALEONE SPAECM2020-11-10
08033707035060LEONE SPALEONE SPAECM2020-11-10
08033707035077LEONE SPALEONE SPAECM2020-11-10