FDA.reportPublic FDA data

Smileloc® BY RODO

Primary DI
00816131023098
Brand
Smileloc® BY RODO
Company
RODO MEDICAL, INC.
Model
80.501
Catalog number
80.501
Device description
Regular Smileloc Seater
Published
2023-06-27
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816131023098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816131023098008161310230988161310230980816131023098

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis handling forcepsA hand-held manual dental instrument designed for grasping and holding a dental implant and/or prosthesis (e.g., crown, bridge, screw) during its application to a patient's oral cavity. It typically has a tweezers-like design consisting of two conjoined blades with serrated tips at the working end; some types have graduated markings on the tips for gauging. It is made of metal [e.g., high-grade stainless steel, titanium (Ti)] and is available in various sizes. This is a reusable device.

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
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03