FDA.reportPublic FDA data

N.A.

Primary DI
EFOR873N99110101
Brand
N.A.
Company
Forestadent Bernhard Förster GmbH
Model
-873N9911-010
Device description
Mand. 1. Bicuspidband right 11 welded
Published
2019-10-01
Public version status
New
Distribution status
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
EFOR873N99110101PrimaryHIBCC0
EFOR873N9911010001Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4972314590info@forestadent.com

Regulatory Flags#

DUNS number
316074384
Device count
10
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
true
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
EFOR5011845Special instrument for opening of BioQui-501-18452024-11-29
EFOR5011846Two pronged probe for BioQuick Brackets-501-18462024-11-30
EFOR4080610001Track bleach-408-06102023-08-11
EFOR129901001N.A.1299-01002020-03-01
EFOR129901011N.A.1299-01012020-03-01
EFOR129901021N.A.1299-01022020-03-01
EFOR32201101N.A.-322-01102020-03-01
EFOR32400010101N.A.-324-0001-0102020-02-01
EFOR32400011N.A.-324-00012020-02-01
EFOR32400020101N.A.-324-0002-0102020-02-01
EFOR32400021N.A.-324-00022020-02-01
EFOR32400031N.A.-324-00032020-02-01
EFOR32400041N.A.-324-00042020-02-01
EFOR32400051N.A.-324-00052020-02-01
EFOR32402001N.A.-324-02002020-02-01
EFOR32402101N.A.-324-02102020-02-01
EFOR16713231001N.A.-167-1323-1002019-12-01
EFOR16912391001N.A.-169-1239-1002019-12-01
EFOR16913231001N.A.-169-1323-1002019-12-01
EFOR16913251001N.A.-169-1325-1002019-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018667815Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECM2025-11-06
10190707120051TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120068TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120075TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120082TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120099TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120105TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120112TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120129TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120136TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120143TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120150TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120167TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120174TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120181TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120198TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120204TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120211TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120228TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120235TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120242TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120259TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120266TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120273TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120280TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120297TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120303TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120310TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120327TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17
10190707120334TruFit™ 2.0Ortho Organizers, Inc.ECM2025-10-17