FDA.reportPublic FDA data

Smileloc® BY RODO

Primary DI
00816131021995
Brand
Smileloc® BY RODO
Company
RODO MEDICAL, INC.
Model
35.001
Catalog number
35.001
Device description
Smilekey Kit
Published
2019-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180609000Rodo SmilekeyRodo Medical, Inc.2018-05-23NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816131021995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816131021995008161310219958161310219950816131021995

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis thermal detacherA hand-held electronic instrument intended to be used by a dental professional to unlock a dental prosthesis (e.g., crown, denture, bridge) from an implant abutment by means of heat application, thereby allowing removing the prosthesis. It is used for abutments designed to be disengaged by heat (i.e., excludes those applied with cement or screws), and is in the form of a handle with a disposable heated tip intended to be placed briefly on top of the prosthesis to be released. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(408)245-7636info@rodomedical.com

Regulatory Flags#

DUNS number
004584361
Device count
1
Kit
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816131025009Smileloc® BY RODO4.7204.7202024-11-18
00816131025016Smileloc® BY RODO5.7015.7012024-11-18
00816131025023Smileloc® BY RODO6.7006.7002024-11-18
00816131025030Smileloc® BY RODO8.7058.7052024-11-18
00816131025047Smileloc® BY RODO70015NEGGM70015NEGGM2024-11-18
00816131025054Smileloc® BY RODO70025NEGGM70025NEGGM2024-11-18
00816131025061Smileloc® BY RODO70035NEGGM70035NEGGM2024-11-18
00816131025078Smileloc® BY RODO70045NEGGM70045NEGGM2024-11-18
00816131025085Smileloc® BY RODO70055NEGGM70055NEGGM2024-11-18
00816131025092Smileloc® BY RODO71715NEGGM71715NEGGM2024-11-18
00816131025108Smileloc® BY RODO71725NEGGM71725NEGGM2024-11-18
00816131025115Smileloc® BY RODO71735NEGGM71735NEGGM2024-11-18
00816131025122Smileloc® BY RODO73015NEGGM73015NEGGM2024-11-18
00816131025139Smileloc® BY RODO73025NEGGM73025NEGGM2024-11-18
00816131025146Smileloc® BY RODO73035NEGGM73035NEGGM2024-11-18
00816131025153Smileloc® BY RODO74515NEGGM74515NEGGM2024-11-18
00816131025160Smileloc® BY RODO74525NEGGM74525NEGGM2024-11-18
00816131024989Smileloc® BY RODO1.7031.7032024-11-15
00816131024996Smileloc® BY RODO3.7023.7022024-11-15
00816131023432Smileloc® BY RODO90.60190.6012024-10-28

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