Primary Device ID | EFOR119900081 |
NIH Device Record Key | 1875ef87-1ce3-432d-905b-ed3157969755 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OrthoEasy® |
Version Model Number | 1199-0008 |
Company DUNS | 316074384 |
Company Name | Forestadent Bernhard Förster GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +4972314590 |
regulatory@forestadent.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EFOR119900081 [Primary] |
NDP | Accessories, implant, dental, endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[EFOR119900081]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-02 |
Device Publish Date | 2019-09-24 |
EFOR129910061 | OrthoEasy Pal Blade for Retaining Screw |
EFOR129910041 | Palatal abutment |
EFOR129910031 | Fixation screw for palatinal pin |
EFOR129900071 | Manual driver with torque control limit 10 Ncm |
EFOR119910401 | Ortho Easy pilot drill ø 1.0 x 4 mm |
EFOR119900151 | Ortho Easy blade 45 mm octagonal f. screw driver |
EFOR119900081 | Ortho Easy blade 10 mm octagonal f. angled hand piece |
EFOR119900071 | Ortho Easy blade 5 mm octagonal f. angled hand piece |
EFOR119900061 | Ortho Easy blade 10 mm octagonal f. screw driver |
EFOR119900021 | Ortho Easy handle f. screw driver standard size |
EFOR119900001 | Ortho Easy Rack (blank) f. implants and instruments |
EFOR1201A23081 | Ortho Easy Palatinal Pin 8 x 1,7 mm |
EFOR1101A23101 | Ortho Easy Pin gold anodized .022" 1,7 x 10 mm (5 pcs.) |
EFOR1101A23081 | Ortho Easy Pin pink anodized .022" 1,7 x 8 mm (5 pcs.) |
EFOR1101A23061 | Ortho Easy Pin rose anodized .022" 1,7 x 6 mm (5 pcs.) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHOEASY 79054323 3623183 Live/Registered |
Bernhard Förster GmbH 2007-11-24 |