FDA.report

Penta-Form

Primary DI
00885797467973
Brand
Penta-Form
Company
Rmo, Inc.
Model
J01292
Device description
PENTA FORM FACEBOW 97MM SIZE 3
Published
2024-08-22
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

Related Records

Product Codes

CodeName
DZBHeadgear, Extraoral, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00885797467973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00885797467973008857974679738857974679730885797467973

GMDN Terms

TermDefinition
Orthodontic face bowA dental device used in conjunction with extraoral traction anchored on the back of the head or neck, as a long metal bow that inserts intraorally into an orthodontic appliance. Generally used to move teeth or bones posteriorly or prevent their forward movement.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007058183
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
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 DIBrandModelCatalogPublished
00885797099730RMOK002502024-09-03
00885797099747RMOK0025022024-09-03
00885797099754RMOK002532024-09-03
008857971002453DK008502024-09-03
008857971002763DK009302024-09-03
00885797098566RMOA070752024-09-02
00885797098870RMOA007882024-09-02
00885797098900RMOJ007702024-09-02
00885797098917RMOJ007712024-09-02
00885797098924RMOJ00771-12024-09-02
00885797099549RMOK000052024-09-02
00885797523693SchweickhardtA041592024-09-02
00885797652812Mini TwinKM134022024-09-02
00885797674265TruLockJ040032024-09-02
00885797674272TruLockJ040052024-09-02
00885797692184Mini TwinKM135002024-09-02
00885797692191Mini TwinKM135022024-09-02
00885797692207Mini TwinKM135502024-09-02
00885797692214Mini TwinKM135522024-09-02
00885797695277Alpine SLKM221022024-09-02

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