# K051812: Tgo Spray

- Pathway: 510(k) (Traditional)
- Applicant: Laboratoires Carilene S.A.S.
- Decided: Oct 21, 2005 after 108 days
- Product code: LFD (Saliva, Artificial)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K874106 (1988). 5 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030802: Caphosol, Inpharma A.S. (2003) Summary page 1.
- K981693: Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25, Gebauer Co. (2001) Summary page 1.
- K024148: Salinum, Orclair, Sinclair Pharmaceuticals, Ltd. (2003) Summary page 1.

## Most influential descendants
- K061331: Oral Balance Liquid/ Gel (2006), 13 descendants of its own
- K101477: Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash (2010), 6 descendants of its own
- K062653: Mouthkote Oral Moisturizer, Model 50930-098 (2006), 3 descendants of its own
- K111250: Dry Mouth Mouthwash (2012), 2 descendants of its own
- K103745: Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief (2011), 2 descendants of its own

## Indications for use
Under the supervision of a healthcare professional, TGO Spray® is intended to provide relief from chronic and temporary xerostomia (dry mouth), which may be a result of disease such as Sjdgren's Syndrome, oral inflammation, medication, chemo or radiotherapy, stress or aging. TGO Spray® relieves symptoms of dry mouth such as difficulties in swallowing, speech, and changes in taste.

Source page: https://510kreport.com/device/K051812
Methodology: https://510kreport.com/methodology