AccessGUDID - DEVICE: Dentsply Sirona (D0026344020)

GUDID

Device Identifier (DI) Information

Brand Name: Dentsply Sirona
Version or Model: 634402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 634402
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026344020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Amalgam Bonding Accessory Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	AGENT, TOOTH BONDING, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964525	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use.
Special Storage Condition, Specify: Keep out of direct sunlight, and store in a well-ventilated place at room temperature.
Special Storage Condition, Specify: Protect from moisture. Do not freeze. Do not use after expiration date.
Storage Environment Temperature: between 2 and 24 Degrees Celsius
Special Storage Condition, Specify: Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3c4985b4-9bda-4c50-babe-1f1bcc92bd10
Public Version Date: February 16, 2024
Public Version Number: 2
DI Record Publish Date: August 16, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)532-2855
Email: MilfordDE-Customer-Service@dentsplysirona.com

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