FDA.reportPublic FDA data

Smileloc® BY RODO

Primary DI
00816131023456
Brand
Smileloc® BY RODO
Company
RODO MEDICAL, INC.
Model
6.600
Catalog number
6.600
Device description
Smileclip Housing
Published
2024-10-28
Public version status
New
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
EJXAnchor, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJXAnchor, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816131023456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816131023456008161310234568161310234560816131023456

GMDN Terms#

Term, Definition table
TermDefinition
Sliding dental precision attachmentA device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
004584361
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
07640239932098Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
07640239932104Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
08059224207810OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224208169OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224001661OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224108865OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224136905OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165189OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165196OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165202OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224166117OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168135OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168173OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168180OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224169910OT EQUATORRHEIN 83 SRLEJX2025-07-07
D990CTB1PK0Cementable TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PK0Pre-Coated TiBase 10PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKEX0Pre-Coated TiBase 10PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKIT0Pre-Coated TiBase 10PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKOA0Pre-Coated TiBase 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PK0Pre-Coated TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKEX0Pre-Coated TiBase 1PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKIT0Pre-Coated TiBase 1PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKOA0Pre-Coated TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKOA0Recharge Kit w/ Tall Spare Parts, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKPOCOA0Recharge Kit w/ POC, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990SFA10PKDKOA0Separable Fastener Assembly 10PK - Drill Kit Included, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990STB1PK0Standard TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990STB1PKOA0Standard TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990TC10PKOA0Temporary Cylinder 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19