FDA.reportPublic FDA data

Smileloc® BY RODO

Primary DI
00816131021827
Brand
Smileloc® BY RODO
Company
RODO MEDICAL, INC.
Model
32.001
Catalog number
32.001
Device description
Disposable Tip
Published
2017-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K160786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160786000RODO Abutment SystemRodo Medical, Inc.2016-11-21NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816131021827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816131021827008161310218278161310218270816131021827

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis thermal detacher tipA removable endpiece intended to be attached to a dental prosthesis thermal detacher handle to apply heat to a dental prosthesis (e.g., crown, denture, bridge) in order to unlock it from an implant abutment. It is used for abutments designed to be disengaged by heat (i.e., excludes those applied with cement or screws). This is a single-use 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
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
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