FDA.reportPublic FDA data

Turbo-CR

Primary DI
00766054002987
Brand
Turbo-CR
Company
ESSENTIAL DENTAL SYSTEMS, INC.
Model
1100-30
Catalog number
1100-30
Device description
Mixing Tips
Published
2025-04-04
Public version status
New
Distribution status
Not 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
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766054002987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766054002987007660540029877660540029870766054002987

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(201)487-9090udi@edsdental.com

Regulatory Flags#

DUNS number
101147171
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00766054002994Turbo-CR1100-001100-002025-04-04
00766054003007Turbo-CR1100-1001100-1002025-04-04
00766054002949BIOSEAL1640-001640-002024-10-31
00766054002970BIOSEAL1640-151640-152024-10-31
00766054000341EDS Self Etch Bonding Agent900-00900-002017-02-01
00766054000693Tango-Endo5300-005300-002020-07-17
00766054001201Endo-Express5510-005510-002020-07-10
00766054001218Endo-Express5520-005520-002020-07-10
00766054002710Endo CSV5100-005100-002020-07-17
00766054002727Endo CSV5121-005121-002020-07-17
00766054002734Endo CSV5125-005125-002020-07-17
00766054002840Endo CSV5100-RH5100-RH2020-07-17
00766054000259EZ-Fill Bi-Directional Spiral1600-211600-212020-07-10
00766054000266EZ-Fill Bi-Directional Spiral1600-251600-252020-07-10
00766054000273EZ-Fill Bi-Directional Spiral1600-011600-012020-07-10
00766054000280EZ-Fill Bi-Directional Spiral1605-211605-212020-07-10
00766054000297EZ-Fill Bi-Directional Spiral1605-251605-252020-07-10
00766054000303EZ-Fill Bi-Directional Spiral1605-011605-012020-07-10
00766054001188Endo-Express5500-005500-002020-07-10
00766054001195Endo-Express5500TEP5500TEP2020-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791021110DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023020DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023030DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102305TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102335TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023580DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791023590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G879102477TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-25
G8791024320DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791024330DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791024340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-23
G8791023940DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-10
G879102GS10DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS20DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS30DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102GS60DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H1H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H2H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G879102H3H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEIY2026-08-08
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20