FDA.reportPublic FDA data

Rodo Abutment Accessories

Primary DI
00816131021902
Brand
Rodo Abutment Accessories
Company
RODO MEDICAL, INC.
Model
40.103
Catalog number
40.103
Device description
Abutment Screws for Neodent: CM Multi-Unit 17º, 30º Abutments and Neodent CM Wide Abutments - All Gingival Heights
Published
2016-12-07
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
00816131021902PrimaryGS10
10816131021909Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816131021902008161310219028161310219020816131021902
1081613102190910816131021909

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
004584361
Device count
10
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

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Primary DI, Brand, Company table
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